Jobs that Crossed My Desk from March 1 - 8, 2009

Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.

ePharmaExpo.com uses the internet to conduct trade shows for the pharma and life science industries.  Besides having exhibitions, ePharmaExpo.com also has a unique click-by-state job bulletin (www.ePharmaExpo.com/job) that is easy and fun to use.  For jobs in California, simply go to the link and click on CA.  Alternatively, one can click on Advanced Search to put in more search criteria. 

The following is a list of job postings in the Bay Area:Account Consultant – RegulatoryAssociate Director, Business Development Senior Medical Director, Clinical Science  ($265,000 - $325,000 per year)Director, Clinical DevelopmentDirector, Medical WritingSenior Director, BiometricsTo apply, please follow the instructions associated with each job posting.ePharmaExpo.com has received many requests from employers and recruiters to search our resume database.  We encourage our job-seeking visitors to post their resumes to make themselves visible to our inquiring employers.

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Heather Reed Executive Recruiter, Quality Control Fortune Bio-Medical Group505 W. Hollis StreetNashua, NH 03062p: 603/880-4900e: heather@fpcnashua.com

QC Manager/Sr. Manager( Cambridge , MA )  Company Information Biotherapeutic company that focuses on the discovery, development, manufacture, and commercialize novel biotherapeutics to treat cancer, neuromuscular, and metabolic disease.  The company maintains a unique culture, team and approach that can rapidly translate ideas and assets into drugs that will make a significant impact on patients lives. The Director that this position reports into has a great reputation in the industry as an excellent mentor and leader.

Job DescriptionSummary:  Quality Control professional (with experience in Bioassays, Potency Assays, ELISA, etc)

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to manage testing and reporting for biological products for a brand new laboratory. Position includes method qualification and validation, as well as planning and execution of release testing of drug substance and drug products for use in pre-clinical and clinical studies.

Required Skills Extensive familiarity with Bioassay and Potency Assays  Minimum 10-15 years of relevant work experience in project management within the Biotechnology field and aGMP Quality Control laboratory. Extensive familiarity with current regulations (FDA, EU, ICH, etc.).Strong and effective organizational, communication, presentation, and writing skills. Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel, various levels of management. Education: B.S. or M.S. in life sciences or other biologics-related discipline required Knowledge of USP Raw Materials is preferred.

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Behzad Behrooz

bbehrooz@gmail.com

Here at Broncus Technologies we have an opening for "Sr. Quality Engineer".Please send me your resume or contact me for more info, if interested.

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Matthew RyanRecruiterPharmatech Professionals100 East San Marcos Blvd.Ste. 400www.pharmatechpro.com <http://www.pharmatechpro.com/> P: 888-279-1900 Fax: 760-510-5901From: Matt Ryan [mailto:mryan@pharmatechpro.com

I was referred to your organization by a member. I am a recruiter and am inthe midst of an URGENT search for a Senior Quality Assurance Engineer.

The client I am working with is located in Mountain View. They are amedical device manufacturer of combination drug/device products. Theirareas of treatment are respiratory and pulmonary disease. We placed theVice President of Quality a short time ago, and he is continuing theirexciting period of growth. Their product is newly developed technology andthis company is poised for tremendous success in the near future.

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The Senior Quality Assurance Engineer is going to have his/her handsinvolved with product from R&D thru Production. Not only will this personbe managing processes/programs, but they will be implementing and developingthem as well. A full knowledge and familiarity with FDA, ISO, MDD and otherregulations and certifications is a must.

I cannot stress this enough: This is an IMMEDIATE need; our client isinterviewing as we speak. I would like to speak with anyone interested inthis role.

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Davidmiller27@sbcglobal.netI work for an small, exciting start-up that is actively hiring in beautiful Austin, TX. See www.apolloendo.com

Please contact me if you or anyone you know might qualified and interested in any of the positions below or you would like more information. No recruiters please.

Senior Design Engineer

Apollo Endosurgery, an exciting Austin-based medical device company, is seeking the right candidate for a Senior Design Engineer position. Join one of the fastest-growing companies in Austin, with features in Newsweek and Time magazine.

Primary function: With guidance from the design team, the Design engineer will research, design, and develop innovative endosurgical products and custom components. The position will be responsible for contributing to the development and management of R&D projects fromconcept through design and manufacturing. Must be able to work with a team and as an individual contributor. Core skills in design, manufacturing, prototype evaluation, and validation of medical devices is required.

Specialized Knowledge and Skills:

* Bachelor's degree in Engineering, Mechanical preferred.* 5+ years experience working in the medical device development and manufacturing industry is required.* Excellent knowledge and understanding of medical regulations & their impact on business, ISO (International Organization for Standardization) & GMP (Good Manufacturing Practices).* Experience with Design/Process/Use FMEAs.* Excellent skills with 3-D modeling and drafting software (Solidworks preferred)* Experience in design for manufacturability.* Enjoys a work environment with a sense of urgency and personal ownership to meet company timelines and objectives.* Experience with design verification and validation.* Excellent oral communication skills.

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* Excellent documentation skills (Specification, Test Plan, Test Report, etc.)._______________________________________________________Design Engineer

Apollo Endosurgery, an exciting Austin-based medical device company, is seeking the right candidate for a Design Engineer position. Join one of the fastest-growing companies in Austin, with features in Newsweek and Time magazine.

Primary function: This individual will be responsible for bringing a product from concept through design to production. The Senior Design Engineer will interface with cross-functional teams, clinical advisors and vendors for evaluation of new products as well as address design issues/ maintenance of existing ones. This position will take product/process concepts and prepare layouts, mechanical designs, tolerance analysis, and detailing of flexible instruments utilizing SolidWorks. Successful candidates must be creative and have the ability to multi-task and work effectively under deadlines and timeframes. Must be able to work with a team and as an individual contributor.

Specialized Knowledge and Skills:

* Bachelors degree in Engineering, Mechanical preferred.* 5+ years experience working in the mechanical design, development, and manufacturing. Medical device industry experience preferred.* Excellent skills with 3-D modeling and drafting software (Solidworks preferred)* Innovative problem solver with ability to work independently and in a team environment* Some knowledge and understanding of medical regulations & their impact on business, ISO (International Organization for Standardization) & GMP (Good Manufacturing Practices).* Excellent oral communication skills.* Some Experience with Design/Process/Use FMEAs.* Enjoys a work environment with a sense of urgency and personal ownership to meet company timelines and objectives.* Excellent written and oral communication skills.* Some documentation skills (Specification, Test Plan, Test Report, etc.).______________________________________________________Senior R&D Technician

Apollo Endosurgery, an exciting Austin-based medical device company, is seeking the right candidate for a Senior R&D Technician position. Join one of the fastest-growing companies in Austin, with features in Newsweek and Time magazine.

Primary function:

This individual will work closely with the engineering team to prototype and evaluate a product from concept through design to production. The Senior R&D Technician willSuccessful candidates must be creative and have the ability to multi-task and work effectively under deadlines and timeframes. Must be able to work with a team and as an individual contributor.

Specialized Knowledge and Skills:

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* 5+ years of prototype experience in the medical device industry.* Deep skills in the materials, design, and manufacturing of flexible instruments or catheters.* Experience developing and prototyping complex products from concept through commercial release.* Some experience with design controls within a regulated industry.* Some experience with a 3-D modeling and drafting software (Solidworks preferred).* Modeling and detailing of therapeutic device designs utilizing the SolidWorks design software.* Development of test methods for design verification and validation.* Technical report writing as needed.* Good written and oral communication in English.* Innovative problem solver with ability to work independently and in a team environment.* Enjoys a work environment with a sense of urgency and personal ownership to meet company timelines and objectives.

Contact for questions and to send your resume:Bryant MadoreExecutive Recruiter

216 East Chatham Street, Suite 101Cary, NC 27511Phone (919) 465-7290Fax: (919) 465-7281Email: bryant@jtlservices.comLogistics Manager  Our client, a leading manufacturer of hi-tech metal devices, seeks a Logistics Manager for its west coast bay area office.

SUMMARY

Directs and coordinates activities of personnel engaged in the planning, coordination and expediting the flow of materials, parts, and assemblies between sections or departments by performing the following duties.

- Works with other departments to provide the customer with a promise delivery date for each specific sales order line item.

- With accuracy and timeliness enters the sales orders in the MRP (Manufacturing Resource Planning) system.

- Works with the Sales and Marketing Department to enter and update sales forecasts in the MRP system.

- Updates the due dates of sales orders and work orders.

- Reviews production schedules and related information with the Manufacturing Department to

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determine overdue items.

- Informs the customer and General Manager of items that will not meet the promised ship date.

- Requisitions material and establishes sequential delivery dates to departments, according to job order priorities and material availability.

- Works with other departments to ensure that the released work orders have the accurate and latest revision of product structures and manufacturing routings.

- Arranges in-plant transfer of materials to meet production schedules.

- Validates the amount of material required to complete work orders is accurate.

- Uses the MRP system to compile Inventory Reports

- Maintains the following measurables: On Time Delivery Performance, Customer Returns, Scrap Shipments, Project Revenue for current quarter based on actual sales orders

- Moves or transports materials from one department to another.

- Creates rework work orders.

- Directs subordinate employees in the organization and maintenance of the stockroom

- Approves inbound and outbound freight methods. ________________________________________________________________________Quality Manager  We have a client, a leading manufacturer of hi-tech metal devices, seeks a Quality Manager for its west coast office

Requirements:

Minimum - BS with related quality management experience. Candidate to be knowledgeable in ISO 9001 or QS 9000 and FDA 13485 quality systems, statistics, Gauging and Product Inspection methods, FMEA, Process Control Plans, document control systems/philosophies and have the ability to run and manage Quality/Process improvement teams. Ability to develop plans and obtain agreed upon goals within the established timelines and budget.

Job responsibilities:

Manage shop floor inspectors, document control, and quality engineer to insure compliance with both internal and ISO procedures and uninterrupted product flow to our customers. This includes identifying process improvements opportunities, communicating with customers for quality concerns and specification issues, and providing quality costs as part of our quoting process.

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In addition to the responsibilities listed above the candidate should be comfortable working in a team environment, have good written and oral communication skills, be self motivated, and have good organization and project management skills. Responsible for generating the departmental budget and operating within plan guidelines. This position will report to the V.P./General Manager

Desired:

Working knowledge of Microsoft office experience, general metallurgy or materials science knowledge, application/customer experience, medical device or related experience preferred

General:

The company is IS0 9001 and FDA 13485 certified and the applicant would be required to become familiar with our systems and the procedures that support this certification. As part of our continuous improvement efforts part of each persons’ responsibilities is process improvement and problem solving for existing processes and operations.  *****************************************************************************Please email your resume to, jasmine.shu@onassignment.com and use "Process Engineer Manager" as the subject line. Process Engineer Manager –permanent position

- Manage preventative maintenance and repair on all PCBA manufacturing equipment - Manage repair parts inventory for all PCBA manufacturing equipment - Manage team of Process Engineers that support PCBA manufacturing equipment including: • Monitoring and improving PCBA process efficiencies • Monitoring and improving PCBA manufacturing quality - Provide technical leadership and training to production teams

Requirements:

- BS in engineering or equivalent experience - Prefer experience running Siemens pick and place equipment - Candidate must have a strong SMT and process background - Supervisory experience is preferred as this individual will be required to lead a team of 6-10 people On Assignment - Lab Support places chemists, biologists, biochemists, microbiologists, molecular biologists, research associates, and other skilled professionals on temporary assignments and in direct hire positions in the biotech, pharmaceutical, medical device, clinical research and other science industries. We’re not just filling jobs –we’re building careers! We offer competitive pay and excellent benefits including medical, dental, 401K, long and short-term disability, stock options, appreciation bonuses and more!ONLY LOCAL CANDIDATES WILL BE CONSIDERED. ******************************************************************************************

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Please resumes sent to hr@alter-g.com. Subject line should be: requisition no. 090302erk. Sr. Document Control Specialist / Drafter  

AlterG, Inc. (www.alter-g.com) is growing medical device company based in Menlo Park, CA.  We design and engineer products used for rehabilitation, neuromuscular and geriatric conditioning, and high performance athletic training.  AlterG’s products revolve around our core patented technology which allows users to alter the effective bodyweight of the user, meaning the user can either weigh more or less than normal while they move and exercise.  This has important implications in the speed and effectiveness in recovering from an injury, treating a neuromuscular disease, or surpassing current limits on human performance. Currently customers include: Palo Alto Medical Hospital, Cornell Hospital for Special Surgery, Los Gatos Medical Hospital, the US Olympic Committee, AC Milan, Chicago Bulls, Los Angeles Lakers. Please visit our website: www.alter-g.com for more details. Position:We are looking for a Sr. Document Control Specialist / Drafter with 3-5yrs experience and a strong background and skill set in engineering and production document creation, document control systems and implementation, and a strong sense of pride in their work and attention to detail.  As our document controller, we are looking for you to work closely with the engineering and production personnel to play a pivotal role in creating new drawings, maintaining and updating existing drawings, and putting in place the framework to track document revisions and implement engineering change orders.  AlterG is a very versatile and fast paced environment where teamwork and an enthusiasm to “get the job done” are valued highly.  You may be called upon to assist in other tasks from time to time, though your focus will be on putting in place and maintaining a streamlined and efficient document control system for the engineering team. You will be responsible for:

-          Participation in choosing the type of document control system and/or software that’s needed. For example, PDM Works/Enterprise PDM.

-          Implementation of the software and training of the relevant personnel.-          Working with the ISO implementation team to ensure compliance.-          Working with cross functional teams to optimize and harmonize change control

procedures for maximal effectiveness.-          Creation of SOP’s to comply with ISO 13485 requirements.-          Creating of new engineering documentation and checking for tolerance callouts and

manufacturing instructions. You may also be involved in helping the production team with vendor selection and working with vendors to understand or modify documentation as needed, and you will report to the Director of Engineering. Engineering Requirements:

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- 3-5 yrs experience in related fields- Implemented a document and product data control system in the past.- Understand fundamentals of standard practices in creation of engineering and production drawings including proper tolerance callouts and manufacturing instructions symbols and detail. Engineering Pluses:

-          Electrical and PCB document creation  General Requirements:- detail oriented.- organized and consistent. - an excellent written and oral communicator- able to take the initiative and action oriented- able to communicate with the manufacturer or vendor about technical issues.- able to learn quickly- comfortable working in a fast paced and dynamic small company.- Proficient with MS Office especially Excel.- 3-5 years experience working in a medical device company and GMP/ISO environment To apply for this position, please send your resume to apply-JL001 "at" Relypsa.com and specify Job Code JL001 (Sr. CRA) in the subject line.Senior Clinical Research Associate (Job Code JL001)                                     Relypsa, Inc. is a biopharmaceutical company leading the discovery and development of new non-absorbed polymeric drugs for important applications in cardiovascular and renal disease.  The new company is a spin-out of Ilypsa, Inc., a wholly-owned subsidiary of Amgen Inc. (acquired by Amgen in July 2007 for $ 420 M). Relypsa commences operations with rights to a proprietary drug discovery platform and a pipeline of product candidates including a potassium binder drug candidate for the treatment of hyperkalemia, known as RLY5016, as well as a novel sodium binder, RLY102, for the potential treatment of congestive heart failure.  Relypsa is dedicated to discover additional product candidates through use of its proprietary polymer platform.DEPARTMENT: ClinicalJOB CODE: JL001 The Senior Clinical Research Associate will oversee work assignments and deliverables for Contract Research Organizations (CROs), independent Consultants and/or other resources. This person will be responsible for in-house management of studies including pre-study site evaluations, site initiations, interim monitoring and site close out activities. The Senior Clinical Research Associate is responsible for meeting overall clinical operational timelines from study start-up activities to completion of the clinical study report.DUTIES/RESPONSIBILITES:Essential activities and skills include but are not limited to:

Provide overall project management to study.  Work with CRO to manage the sites in Europe to ensure that patient enrollment goals are met.

Monitor input for clinical program plans, protocols and timelines for assigned projects. Assures site compliance with protocol, regulatory requirements and quality of data.

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Manage all site-related study start up activities, including investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions, negotiation of Clinical Trial Agreements and Investigator Grants, Investigator Meetings and/or Site Initiations.

Coordinate and create necessary materials for clinical trial training for investigative site personnel and CRAs as necessary.

Confirm study sites' adherence to pertinent regulations with regards to protection of subject's rights and safety through review of monitoring reports, QA-GCP audits and communications with CRO CRAs, CRO Project Managers and/or study site personnel.

Oversee the collection of and validate all study and site-specific regulatory documentation necessary for initial drug shipment and filing of the IND and NDA.

Assign, manage and track the completion, quality and timeliness of tasks and deliverables for CROs, evaluate CRO performance via co-monitoring visits, and document in co-monitoring visit reports.

Plan, track and conduct follow-up on all site GCP and vendor audits as required. Coordinate and generate necessary materials for clinical trial initiation. Contribute to generation, refinement and maintenance of Clinical Affairs infrastructure,

primarily SOPs and Work Instruction Guidelines. SKILLS/EXPERIENCE:

Fundamental working knowledge of ICH and FDA GCPs, and US IND and NDA regulations. Therapeutic experience and knowledge in cardiovascular and particularly in CHF trials are

desired. Experience outside the US is highly desirable. Study experience in Eastern Europe is a plus Proficiency in MS Word, Excel and PowerPoint. Ability to multitask is required. Excellent organizational, written and oral communication skills. Highly self-motivated and able to work effectively with minimum supervision. Proficiency at building consensus when working within a team setting. Willing to travel within the US and abroad (~25%).

QUALIFICATIONS: Bachelor's degree is required with an emphasis in a scientific or health-related field. Minimum off 2 years experience as a Clinical Research Associate OR at least 5 years of

clinical research experience in the biotech, pharmaceutical or contract research organization arenas, or any combination thereof.

Relypsa offers a competitive benefit and compensation package including pre-IPO stock options.EOE To apply for this position, please send your resume to apply-JL002 "at" Relypsa.com and specify Job Code JL002 (CTA) in the subject line.

Clinical Trial Assistant (Job Code JL002)       Relypsa, Inc. is a biopharmaceutical company leading the discovery and development of new non-absorbed polymeric drugs for important applications in cardiovascular and renal disease.  The new company is a spin-out of Ilypsa, Inc., a wholly-owned subsidiary of Amgen Inc. (acquired by Amgen in July 2007 for $ 420 M). Relypsa commences operations with rights to a proprietary drug discovery platform and a pipeline of product candidates including a potassium binder drug candidate for the treatment of hyperkalemia, known as RLY5016, as well as a novel sodium binder, RLY102, for the

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potential treatment of congestive heart failure.  Relypsa is dedicated to discover additional product candidates through use of its proprietary polymer platform.DEPARTMENT: ClinicalJOB CODE: JL002Under minimum supervision provide administrative and project specific support related to the conduct of all types of clinical trials with Clinical Development.  This includes assisting with project management activities, performing administrative and clerical duties required to run the clinical program.  This position reports to the Associate Director of Clinical Operations.DUTIES/RESPONSIBILITES:Project management; assists with the following activities: Contact investigator sites to provide study specific information. Facilitate flow and maintenance of correspondence with vendors and teams Attend clinical study team meetings. Study contract and budget management, invoice receipt processing and tracking. Assist in coordination and planning of study management process. Performs Clinical Assistant duties, as directed: Coordinate distribution of study team materials and meeting minutes. Set up and maintain clinical trial files. Track clinical studies in assigned software. Draft and prepare documents for mass mailings. Assists with preparation of presentation materials. Set up teleconference calls with sites and study team and record minutes. Assist and direct off-site and on-site Investigator Meetings with meeting planners. Help to develop standards for processing of clerical and study management tasks. Provide administrative support to clinical group as well as the management team. Serve as a resource for and interacts with other functional areas and departments to facilitate study timelines and/or tasks. Perform other tasks as assigned by manager. SKILLS/EXPERIENCE: Knowledge of medical terminology preferred. Knowledge of corporate software highly preferred. Proficiency in MS PowerPoint, Excel, Word, and Outlook. Demonstrate ability to work independently and exhibit initiative. Excellent verbal and written communication skills to interact in a team oriented environment required. QUALIFICATIONS:Minimum requirement include a high school diploma.  A 2-year degree in the scientific or healthcare field is desired. 2+ years of relevant work experience in the pharmaceutical industry. Relypsa offers a competitive benefit and compensation package including pre-IPO stock options.EOE**************************************************************************Please email your resume to, Heather.Keller@onassignment.com and use "R & D Engineer" as the subject line.R&D Engineer-Medical Device 

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THE SITUATION We are looking for a special person to work with a talented team and take a key role in our Manufacturing group. This person will be responsible for tracking activities associated with getting our product ready to be manufactured and sustaining the product once released into manufacturing. As such, he/she will take ownership of, and significantly contribute to the success of the launch of our first product. This person will also play a significant role in the management of outsourced manufacturing resources. Travel of up to 30% is expected.

THE IDEAL CANDIDATE The candidate selected to fill this position will have: • a BS in Engineering or Science, or Math from a top school with at least 2 years of experience performing biomedical laboratory research • experience with designing, setting-up and performing experiments • experience collecting data in laboratory notebooks and translating data to presentable formats • significant knowledge of statistical/data analysis tools • experience writing procedures and training technicians to perform experiments • exceptional interpersonal/written communication skills • experience with LabView and analytical tools such as MathCad • experience working with blood is a plus • the ability to thrive in a highly collaborative, fast-paced, team-based environment • a desire to have fun, be creative, and deliver extraordinary results We offer competitive pay and excellent benefits including medical, dental, 401K, long and short-term disability, stock options, appreciation bonuses and more!ONLY LOCAL CANDIDATES WILL BE CONSIDERED.

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**Please email your resume to, jasmine.shu@onassignment.com and use "Sr. Quality Engineer" as the subject line. 

Sr. Quality Engineer 

Job Description: We are currently looking for a Senior Quality Engineer to support all quality initiatives with new product development and compliance activities. The candidate will take a lead role in formalizing functional and system level specifications along with utilizing effective quality tools and techniques to meet product compliance to CE marking and QSR requirements. This individual will be responsible to ensure all documentation, reports, tests and results meet the requirements of the 510k and the Technical file for CE filing.

Responsibilities: • Develop new Quality Plans and strategies, Master Validation plans, Design and Verification plans, Quality compliance documentation of suppliers and contractors. • Ensure appropriate design controls are used during the product development process. • Effectively use Process Excellence Methodologies to solve quality issues.

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• Partner with Operations, Manufacturing partners, R&D Operations and other departments to ensure products are effectively transferred to contract Manufacturers. • Support and assist all compliance activities focused on achieving and maintaining compliance with ISO 13485, MDD 93/42/EEC, IVDD, CE Mark and FDA QSR compliance.

Requirements: • Proactive, team player, enthusiastic, with high work ethics, preferably with start up experience • BS Degree in Engineering, ASQ CQE/CQA preferred • Excellent documentation writing and reviewing skill with 8-10 years experience in quality assurance / engineering field in medical device industry. • Knowledge of QSR, ISO13485, MDD, CE Marking requirements • PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) • Excellent written and oral communication skills • High level of attention to details, capable of efficient use of time and project management skills essential • Co-ordination of engineering activities with remotely located collaborators and contractors is essential. • Regulatory knowledge is an added plus.   

We offer competitive pay and excellent benefits including medical, dental, 401K, long and short-term disability, stock options, appreciation bonuses and more! 

ONLY LOCAL CANDIDATES WILL BE CONSIDERED.

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**Please email your resume to, jasmine.shu@onassignment.com and use "Process Engineer" as the subject line.Process Engineer

Job Description: We are seeking a self-motivated, creative and independent thinking individual for a Process Engineer position. In this role, you will be a member of the Process R&D team and will make important contributions to the development and scale-up of pharmaceutical compounds. You will conduct process development studies and support production activities in our new kilo-laboratory facility.

Qualified candidates will have a BS in Chemical Engineering with 1-3 years of experience in the chemical/pharmaceutical industry. Familiarity with GMP is a plus. The ability to work independently in the laboratory is essential. Strong organization and communication skills are required.  

We offer competitive pay and excellent benefits including medical, dental, 401K, long and short-term disability, stock options, appreciation bonuses and more!

ONLY LOCAL CANDIDATES WILL BE CONSIDERED.

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****************************************************************************Please send resumes to hr@autonomictechnologies.com  PRODUCT DEVELOPMENT ENGINEER  Autonomic Technologies is a small, early stage start-up company developing implantable neuromodulation therapies.  Founded in late 2007 with initial funding from Kleiner Perkins Caufield and Byers, ATI is working in collaboration with the Cleveland Clinic to develop this technology for headache patients. POSITION DESCRIPTION: Responsible for project management and technical communication with vendors who are developing various software and electrical components of an implantable stimulator system.  Hands on familiarity with software and hardware development is highly desired as is a willingness to assist in other areas as needed including hardware/software prototype development, ordering parts, and writing and reviewing FDA level documentation.  Positive attitude, ability to communicate well, work independently, and finish projects to completion are all essential attributes.POSITION REQUIREMENTS: ..          Bachelors Degree in Biomedical, Electrical, or Software Engineering,or related field plus 4 years working for medical device companies.  ..          Project management experience is desired as is familiarity withwriting FDA level documentation...          Ability to develop, test, and debug software and hardware prototypes..          C language programming..          Hands on electronics experience..          Experience with high level programming language such as C# orLabVIEW We offer a terrific location next to the San Francisco Bay with a wonderful view of a plethora of wildlife. We offer a competitive benefits package.  We are confident, you will enjoy working with our team of intelligent and innovative professionals. 

*******************************************************************************Ryan KallenbergerConsultant, Clinical Affairs and MarketingAPT Medical Consulting253-853-3707x101www.aptmedical.com <http://www.aptmedical.com/>

It was a pleasure speaking with you this morning. If you can think ofanyone from your past work places that understands how to use imagingequipment with reference to single and bi-Plane C Arms including thedifferent views when using fluoroscopy I have a great Medical device companylooking in the Santa Clara area. Thanks for your time and help.

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Here is a job description outlining a Director of Marketing position I amtrying to fill for a Bay Area company. Interested candidates should forwardtheir resumes to jim@jimbrownassociates.com .Jim Brown Associates15 Southwind CircleRichmond, CA 94804-7405Phone: (510) 235-4472FAX: (510) 235-4482e-mail: jim@jimbrownassociates.com

Title: Director, Marketing

Job Profile Director of Marketing who will be responsible for defining brand and productstrategies, along with their development and implementation. The directorwill also be accountable for commercial and pipeline marketing, interactingwith internal departments, field personnel, and external customers andpatients.

Responsibilities:

.. Define Brand and Product Strategies

.. Interpret and Understand Market and Competition

.. Gather, Identify, Prioritize Functional and Product Requirements

.. Develop Product Roadmap, Collaboratively with Multiple Departments

.. Prepare and Review Marketing Collateral

.. Foster Relationships with KOL's, Clinicians, and Other Key Customersand Stakeholders .. Create Demand and Sales Forecasts, Partnering with Sales and Finance

.. Provide Field Sales Education Materials and Training, IncludingProduct Positioning .. Develop and Evaluate Pricing and Health Economic Models .. Leverage and Respond to Managed Care Implications .. Manage and/or Collaborate with Ad Agencies and PR Firms .. Plan and Execute Events/Trade Shows .. Develop Promotional and Marketing Plans************************************************************************************Jobs that Crossed My Desk from Feb. 22 – March 1, 2009

Ronald H. Coelyn E-mail: rcoelyn@coelyngroup.com

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Phone: 817-424-3652

web: http://www.coelyngroup.comOur client produces cutting-edge healthcare safety products, including prefilled syringes and sharps safety devices, for the medical device and pharmaceutical industries. Experience in an automated, high-volume, medical device manufacturing environment is required. Depending upon the qualifications of the individual the title of each position listed below could be Director, Senior Director or Vice President. Our client is rapidly expanding and has other needs beyond the positions in this e-mail.Senior Director/Vice President, Manufacturing This person will direct and coordinate manufacturing facility expansion and renovation including new equipment IQ/OQ/PQ for the Company's innovative Plastic Injection Molded products for the healthcare pharmaceutical and medical device industries. He/she will set manufacturing performance goals, monitor and review performance and ensure continuous improvement of all manufacturing operations.Senior Director/Vice President, Supply Chain Management This person will provide leadership and management for all supply chain processes including, but not limited to, selection and qualification of suppliers, negotiation of contracts, sales and operations planning, material forecasting, inventory management and optimization, purchasing, logistics, and warehousing for the healthcare pharmaceutical and medical device industries.Senior Director/Vice President, Project Engineering -- Pre-filled Syringes This person will direct and coordinate project controls services (scheduling, resource planning, and cost analysis) for product development and engineering capital projects, utilizing widely diversified knowledge of project controls activities, and drawing upon extensive experience and exposure to various projects.These individuals will be key members of the manufacturing operations team.The positions will all be located at the Company's primary manufacturing facility which is in Western Pennsylvania.We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals; and finally, people whose track record of accomplishments and contributions are unambiguously clear.

************************************************************************ This Scientist I - Formulation Development job opportunity will be posted soon on our website. If you are interested, you may contact me with your resume for forwarding to the hiring manager.

Thank you,Susanna ChauSuperGen Investor Relations Managerschau@supergen.com email925-560-2845 tel

SuperGen, Inc.Scientist I, Formulation Development

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"Work for a company that is making a difference in the fight against cancer". SuperGen, Inc. (www.supergen.com) brings together high tech and biotech to search for new, more effective drugs for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. The candidate will be working in the Laboratory located in Pleasanton, California.

Develop, optimize and characterize formulation of small molecules for oral and parenteral administration in pre-clinical and clinical studies. Demonstration of oral dosage form development is preferred. This is a bench level position that involves extensive formulation development and reasonable analytical method development skills to the extent of guiding formulation development. Hands-on experience in these areas is required.

This is a bench level position that involves extensive formulation development and reasonable analytical method development skills to the extent of guiding formulation development.

• Perform preliminary analytical method development to support pre-formulation and formulation studies• Conduct pre-formulation activities, such as (pH-dependent) solubility, stability, and excipient compatibility testing of new chemical entities (NCEs). Determine physicochemical properties of NCEs• Develop oral and parenteral formulations of adequate stability for research, pharmacology, toxicology and early clinical studies; Optimize formulations for Phase 1-3 stage clinical trials• Design and conduct stability studies at various stages of formulation development• Characterize prototype formulations and support transfer of corresponding analytical methods to the analytical group• Evaluate the potential for enhancing oral bioavailability of lead drug candidates through conventional or state of the art formulation technologies. Propose and design novel delivery systems as appropriate for the projects• Work closely with analytical and manufacturing groups. Actively support testing of new drug formulations at various stages of development, meeting project timelines and goals• Represent the formulation group in various inter-disciplinary settings and write relevant CMC sections for regulatory filings• Present results at meetings and in technical reports/publications

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Education:

Ph.D. or M.S. in pharmaceutical sciences or equivalent. Ph.D. with 0-2 years experience or M.S. with 5-8 years experience in a pharmaceutical industry.Benefits:We provide a comprehensive benefits package to include medical, vision, dental, short and long term disability, group term life, 401(k) and an Employee Assistance Program. ** **********************************************************************************I have multiple positions in Orange County with an expanding medicaldevice company. Relocation assistance is available for highly qualifiedindividuals. My client develops and commercializes peripheral vascularand neuro vascular catheter based technologies and will be launching 6products this year.

Full job descriptions available. Please direct resumes and inquiries toBrian Volenec at brian.volenec@yoh.com <mailto:brian.volenec@yoh.com> .

Regards,

Brian Volenec

Yoh Scientific

(925) 945-8383 x238

Senior Lean Engineer- BS Mechanical Engineering or Industrial Engineering or related- MS preferred- 5 + yrs mfg process improvement- Medical device experience- Certified Six Sigma Black or Green Belt preferred- Project Management Institute (PMI) training a plus- Working knowledge of Lean tools to include Value Stream Mapping, 5S,Standard Work, Kanban, Single Piece Flow, Pull Systems, Poka-yoke, TotalProductive Maintenance

Senior Quality Engineer- BS Engineering/Life Sciences- 5 yrs med device QA experience- Provides Quality Engineering support and leadership to ensure thesuccessful development of products and design assurance

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- Identifies and manages risk throughout the development process withthe use of FMECA and/or other risk management tools.- Provides input to design and manufacturing documentation includingmaterial specifications, drawings, inspection procedures, andmanufacturing procedures, to ensure that the resulting products can beadequately manufactured and tested- Designs and installs quality process sampling systems, procedures andstatistical techniques- Assures compliance to FDA, ISO and internal Quality Standards forproduct development and manufacturing- Conducts training and supervises other engineers and inspectionpersonnel on Quality tasks

Process Development – Engineering Manager- Oversee the planning, development, implementation, and improvement ofmanufacturing methods, processes, and equipment for new and existingproducts in a Lean Six Sigma environment.- BS Mechanical Engineering or similar discipline; Master's Degreepreferred.- 8 years engineering experience with 3 years in a supervisor ormanagement capacity.- Knowledge of process development for medical device products- Project management and previous budget responsibility.- Hands on- Lean Six Sigma experience and implementation skills.

Process Development – Manufacturing Engineer- BS degree in Mechanical or Materials Engineering is required. 3 yearsof experience.- Knowledge of mechanics of materials- ISO/GMP training and project management/leadership skills a strongplus.- Experience with statistical and analytical methods- Strong mechanical design skills including test methods andtest-fixture design required.- Establish equipment specs and requirements- Develop design and process failure mode and effects docs- Manage process validation plans and reports addressing deviations andnon-conformities- Develop testing equipment and methods for product/assemply/componenttesting

Manufacturing Engineer, Senior- Evaluate and trouble-shoot manufacturing processes, analyze, designand develop processes, tools, equipment necessary to produceneurovascular products in a lean manufacturing environment.

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- BS degree in Mechanical or Materials Engineering is required. 3 yearsof experience.- Knowledge of mechanics of materials- ISO/GMP training and project management/leadership skills a strongplus.- Experience with statistical and analytical methods- Strong mechanical design skills including test methods andtest-fixture design required.- Develop design and process failure mode and effects docs- Manage process validations including writing protocols/reports andpreparing master validation plans and reports- Develop testing equipment and methods for product/assemply/componenttesting

Manufacturing Engineering Manager- Working with Process Development to transfer newly developed productsfrom R&D into production and providing engineering support tomanufacturing through the development of necessary processes, tooling,equipment, training and validations.- BS Engineering- 5 to 10 years experience- Supervisory experience- Med device experience required- Lean Mfg/Six Sigma preferred- Equipment and tooling design

R&D Engineer, Senior- This hands on engineer will be responsible for establishing productrequirements, concept prototyping, conducting and overseeing producttesting, design and development (including verification and validation),material selection, risk/failure mode assessment, performance and safetytesting for neurological delivery catheters- BS mechanical Engineering + 5 yrs or MS + 3 yrs- 3 yrs in catheter design; preferably neuro catheters

Regulatory Affairs ManagerResponsible for participation in and management of identified GlobalRegulatory Affairs project and department activities

Responsibilities:• Management of Peripheral Vascular Regulatory Affairs submissions,with a focus on international submission activities/management• Serve as regulatory representative on identified productdevelopment teams• Participate in US and International regulatory and clinicalprogram strategy, development and implementation

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• Create or review global regulatory submissions that meet companyand regulatory agency requirements• Manage process and communication with our Notified Body relatingto product review and issuance of Product Certificates.• Develop and implement company and departmental SOP's

Experience:• Minimum of 6 years experience in US and OUS medical device orpharmaceutical Regulatory Affairs management and execution, including aminimum of 4 years of US and OUS submission preparation experience• Strong knowledge of IDE, PMA, 510(k), MDD, MHLW, ISO, and QSRrequirements required• Working knowledge of US and OUS clinical research regulations andtechniques required• Experience with MDR, Vigilance, and other regulatory complianceprograms required

Other skills:• Demonstrated ability to effectively implement and manage complexglobal regulatory programs• Demonstrated knowledge of all aspects of regulatory affairsproject execution• Excellent written and verbal communication skills requiredDemonstrated ability to manage people and projects in an effective andpositive manner

Regulatory Affairs Specialist- Plan and execute global regulatory activities necessary to obtain andmaintain regulatory approvals within the United States and Internationalmarkets. Ensure compliance with relevant FDA, MDD, ISO and other globalregulations, for ev3 peripheral vascular products. Participate oninternal development teams, providing US and/or International regulatorystrategy and execution. Ability to lead and execute complex regulatoryprojects. Regulatory review of labeling and advertising, designchanges, and specification changes.- 510(k), IDE and PMA experience (desired)- Knowledge of FDA, EU, MHLW, TGA, and TPP requirements- At least 5 years of US and International medical device regulatorysubmission/approval experience, to include FDA, MDD, MHLW, TGA, and TPP************************************************************************

**********************************Lauren Sowers Scutero, Principal RecruiterSmith Hanley Consulting Group, LLC an inVentiv Health Company (NASDAQ:VTIV)Lauren is on the east coast and her cell is 407-739-9006 if you're interested.The company's product is an IVD for breast cancer.

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Regulatory Affairs Manager (Mountain View, CA): A client in the Bayarea is in need of a Regulatory Affairs Manager for a 6-monthcontract. The qualified candidate will work with VPs to implement theregulatory strategy to move our products to approval as quickly aspossible while remaining in compliance with applicable regulations andguidelines.

Exercises judgment and helps define practices and approaches toachieve results. Manages, develops and advises subordinates. Provides input to budgets, schedules and performance requirements.

Specific Responsibilities:

· Support the assessment of regulatory requirements forclinical, preclinical programs to assure that all developmentactivities are in compliance with applicable regulations and guidelines

· Contributes to regulatory argumentation for submissions

· Plans, prepares and manages timelines for assignedregulatory documentation including initial submissions, meetingrequests, protocol assistance, etc., ensuring that timings aresupportive of the corporate goals. Initiate, collect and coordinateinformation to prepare regulatory documentation packages for reviewand submission to regulatory agencies or to our commercial partners. Initiate and compile materials for license renewals, updates andregistrations

· Responsible for completing the quality control of regulatorydocumentation prior to submission

· Participates on project teams or subteams for the planningof activities needed to meet long term corporate objectives

· Writes and reviews documentation associated with regulatorysubmissions

· Keeps abreast of and communicates changes and meaningfultrends in the regulatory environment in the US and pertinentinternational jurisdictions

· Supports and participates in the development of RegulatoryDepartment systems and processes

· Cooperates and Interacts directly with the regulatory

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operations function to develop submissions

· Cooperates with the RA Team and the cross-functional team topromote an environment of knowledge sharing and team effectiveness

· Assist with the development of regulatory training materialsand training program

· Interacts with the FDA and other regulatory agencies asrequired by senior management to support regulatory goals andobjectives.

· Provides supervision to reporting regulatory professionalsincluding assignment of tasks and deadlines, performance appraisalsand professional development

· Other duties, as requiredExperience, Knowledge, and Skills Required:

BA/BS in the life sciences, with MS preferred

Requires a 7-10 years of related experience in the medicaldevice/pharmaceutical industry, and 3-5 years direct regulatoryexperience.

· Requires experience with complex regulatory submissions formedical devices (IDE, PMA), combination devices. Experience withpharmaceutical regulatory submissions (IND, NDA) is desirable

3-5 years of supervisory experience required

Experience with international device and drug regulations required

Requires initiative, creative, problem-solving ability and superiororal and written presentation skills

Demonstrated project management experience

Regulatory Affairs Certification preferred

*******************************************************************************

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Andrew YoungelsonKey Recruit Inc.www.keyrecruit.com

You should upload your resume at www.keyrecruit.com and send me a copy as a Word document. Please: NO PHONE CALLS.  Include a cover letter explaining why you would be a good fit for this position using the using the keywords in the job requirements as a guide.  Letter should include how your work in the past is relative to client needs in the present. Client wants to know specifics what you did in the medical device space and for whom and for how long, including specifics in medical devices class I, II, III. 

COO & EVP Business DevelopmentDate Posted: 2/12/2009    Job Id: 1671    Company: We are a diagnostic medical device company. We have two platform products in

development. The first product that will be brought to the outside US market is a cervical barrier. Company has acquired the rights to a cervical barrier system which was marketed outside the US as late as 2005. We plan to incorporate additional unique features to the product. It has been shown that cervical barriers have the potential to serve as a barrier against sexually transmitted diseases. Future development is intended to include the potential for use of the cervical barrier as a therapeutic drug delivery system. The second platform product, in development, is based upon a patented technology to develop a point of care, molecular cervical cancer screening test. The system is based on a unique, low cost disposable cartridge utilizing specific molecular markers that can determine the presence of multiple analytes in a rapid point of care manner. The convenience of this test cartridge is such that it will save time and money in the diagnosis and subsequent follow-up and treatment.

   Location: Northern CA or Any Major City in USA    Reports To: CEO and Chairman    Salary: $175k + stock: 500,000 after 90 days of performance review, Bonus- performance

based    Education: Ideal- Technical plus post graduate in business    Requirements: (Eventually President) Capable of filling CEO position in two years. Personality traits:

Open, great verbal and writing skills, honest, trustworthy, communicator, secure in themselves doer vs talker—think outside the box and on their feet. Experience in working in cash restricted environment (control). Medical Device/Diagnostics- 15 years+. International sales via distribution or direct (broader the better). Operational

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experience working with third party manufacturing. QA and Regulatory process (CE mark process critical- managed or involved). Entrepreneurial –vs big company (hands on and a doer).

   Duties: International sales and marketing and rest of world (outside USA) distribution

(establish and control). Work with governmental bodies regarding distribution and training. Manage all aspects of third party manufacturing. Manage all aspects of QA Development and Regulatory via third parties. Think outside the box (demonstrate how they did this). Worldwide travel 25% -35% year one. Present to board of directors-written and verbal. Set up full customer support systems.

Visit www.keyrecruit.com  to view other openings.  

*********************************************************************************Jim Brown Associates15 Southwind CircleMarina Bay – The BreakersRichmond, CA 94804-7405Phone: (510) 235-4472FAX: (510) 235-4482e-mail: jim@jimbrownassociates.com

Title: Director, Marketing Job Profile Director of Marketing who will be responsible for defining brand and product strategies, along with their development and implementation.  The director will also be accountable for commercial and pipeline marketing, interacting with internal departments, field personnel, and external customers and patients.  Responsibilities:

• Define Brand and Product Strategies • Interpret and Understand Market and Competition • Gather, Identify, Prioritize Functional and Product Requirements • Develop Product Roadmap, Collaboratively with Multiple Departments • Prepare and Review Marketing Collateral • Foster Relationships with KOL’s, Clinicians, and Other Key Customers and Stakeholders • Create Demand and Sales Forecasts, Partnering with Sales and Finance • Provide Field Sales Education Materials and Training, Including Product Positioning • Develop and Evaluate Pricing and Health Economic Models • Leverage and Respond to Managed Care Implications • Manage and/or Collaborate with Ad Agencies and PR Firms • Plan and Execute Events/Trade Shows • Develop Promotional and Marketing Plans • Conduct Market Research – Primary, Secondary, Targeting, Segmentation, Analytics

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• Support Field Sales Organization with a Significant Level of Teamwork and Customer Commitment

 Qualifications:

• MBA  Undergraduate degree in basic science, molecular biology, or medical technology preferred

• At least 10 years progressive business experience; marketing/product management experience in IVD, IVDMIA, pharmaceutical, biotechnology, diagnostics, or other related medical field; knowledge of cardiology, pulmonology, or immunology preferred

• Knowledge of transplant markets a plus  • In-depth understanding of sales and marketing to clinicians.  DTC experience a plus • Experience working in Marketing under FDA design control, CLIA, or other regulatory body

required  • Experience launching new products; Full product lifecycle management experience

preferred • Experience managing teams and direct reports • Excellent written and oral communication skills • Strong organizational and time management skills • Ability to manage multiple priorities in a fast paced environment • Demonstrated ability to lead and participate effectively in cross-functional teams • Strong interpersonal and leadership skills • Some travel required **********************************************************************

Elizabeth TseTECHLINK SYSTEMS INC. PHONE: 415-732-7580 x146    Fax: 415-732-7583EMAIL: etse@techlinksystems.comURL: www.techlinksystems.com 

Medical Writer (Title Not Specified—San Francisco Bay AreaParticipate in writing papers and making presentations; participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.; writes study protocols, protocol amendments, Document management, SOPs, PowerPoint slide creation, editing, assisting/incorporating changes in reports (CSR-clinical study reports), annual reports, protocols.  Routing of materials through A and P process.Good grasp of English, written and verbal. Minimum Bachelor's or Master's of Science with writing experience. PhDs with writing experience preferred.Proficiency in MS Word, Excel, PowerPoint, experience or ability to learn.Familiarity with clinical trials or medical documents strongly preferred

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 Must have a writing sample submitted with resume, per manager's request. 1-year contract in Santa Clara.  

*********************************************************************************Below you will find the current update on positions we are working on in medical device.  We have positions in the SF bay area as well as other locations across the country.  You are welcome to pass this along to anyone that may be interested.  If you have any questions, please feel free to get in touch anytime.  (Just to note, recently we have received a great deal of inquiries about openings so it may take a little longer than normal to reply.)  Also, you may review the detailed job descriptions posted on our site at www.chozeninc.com.   Qualified candidates please reply to: Christina Lehrman clehrman@chozeninc.com tel:  925-242-1010 x 104

  Most Urgent Positions: (2) VP of Business Development / Group Director – Ad Agency experience Sr. Clinical Research Associate (spine/fluoroscopy exp.) Sr. R&D Engineer Sr. Product Manager (cardiovascular device experience preferred) Clinical Specialist (cardiac rhythm mgmt) R&D, MANUFACTURING & OPERATIONS ROLES Director of R&D Engineering                                           BS/MS Engineering 15+ yrs R&D experience, 5+ in mgmt overseeing diverse engineering groups (EE, HW, SW, ME) Capital equipment experience Medical device experience Robotics is a plus Sr. R&D Engineer (Mechanical Design)                                                                         BS/MS Mechanical Engineering 10+ years R&D medical device experience, cardiovascular device experience preferred ProE experience strongly preferred, SolidWorks acceptable Full life cycle product development experience – concept to launch Engineering Manager Process Development                                                                             BSME, Masters preferred 8+ yrs engineering experience in medical device, 3+ yrs management capacity Knowledge of process development for medical device products Project management and previous budget responsibility. Lean Six Sigma experience and implementation skills. Manufacturing Engineering Manager BS in Mechanical Engineering or related

5/7/2023 27

Minimum of 6 years of experience in Medical Devices   2-3 years management experience Experience in engineering project management and production supervision Senior Manufacturing Engineer §         BS degree in Mechanical or Materials Engineering is required.  3+ yrs med device experience. §         Knowledge of mechanics of materials and strong problem solving skills.  §         ISO/GMP training and project management/leadership skills a strong plus. §         Experience with statistical and analytical methods and strong mechanical design skills including test methods and test-fixture design required.  Senior R&D Development Engineer for Vascular Products Extensive experience in the mechanical design and testing of medical products - specifically disposable catheter systems used for delivery of neurological implantable devices.   Catheter and/or implantable device experience including writing protocols and reports to support verification and validation activities for product commercialization. Expertise with statistics, ability to analyze data, interpret results and write technical reports. BSME, 5+ years med device experience, 3+ yrs in catheter design specifically   Process Development Manufacturing Engineer BS degree in Mechanical or Materials Engineering is required  A minimum of three years of experience Knowledge of mechanics of materials and strong problem solving skills ISO/GMP training and project management/leadership skills a strong plus Experience with statistical and analytical methods and strong mechanical design skills including test methods and test-fixture design required.   Senior R&D Stent Engineer BS degree in Mechanical or Materials Engineering is required Interact with physicians and outside vendors Previous development experience of endovascular devices and knowledge of endovascular therapies preferred CAD applications (AutoCAD, SolidWorks or ProEngineer) preferred 5 years of related engineering/medical device experience SALES, MARKETING & BUSINESS DEVELOPMENT VP of Business Development / Group Director – Ad Agency Experience strongly preferred 7+ years experience as Sr. Account Lead for reputable Ad Agency or Marketing Firm. Extensive Advertising and Marketing experience Extensive experience developing, selling and executing Marketing/Advertising programs for large clients Experience making high level presentations to C-level marketing professionals Sales Representative – West Coast 5+ years proven track record in sales within medical device industry Orthopedic device sales experience a MUST Role is based in SF Bay Area, travel required Capital equipment experience a major plus VP of Sales and Marketing (ON HOLD)                                                                                         10 – 15 years Sales and Marketing experience in medical device industry Product launch and branding experience Currently operating at V-level

5/7/2023 28

Orthopedic device experience required VP of Marketing 15+ years successful track record in marketing within medical device industry Exceptional strategic marketing skills as well as product launch and branding experience Currently operating at V-level Laparoscopic device experience Extensive commercialization experience RF knowledge helpful Sr. Product Manager (cardiovascular) BA/BS, MBA preferred 5 - 8+ yrs of medical device and marketing experience Experience in cardiovascular devices would be ideal Up/Downstream marketing experience Extensive product launch experience in med device Product Manager – (ophthalmic) BA/BS (MBA a plus) 5+ yrs of medical device and marketing experience Ophthalmic device and capital equipment experience required Strong upstream, product development experience Clinical Specialist (location would be in FL) BA/BS 3 - 4+ yrs experience as clinical specialist in medical device industry Cardiac rhythm management device experience REGULATORY, QUALITY & CLINICAL AFFAIRS Sr. Clinical Research Associate (spine) BS in life sciences, medicine or technical discipline 5 – 8+ years related experience in medical device Spine device experience required Fluoroscopy experience required Ability to travel 30% - 70% depending on needs Manager, Global Regulatory Affairs Minimum of 6 years experience in US and OUS medical device or pharmaceutical Regulatory Affairs management and execution, including a minimum of 4 years of US and OUS submission preparation experience   Strong knowledge of IDE, PMA, 510(k), MDD, MHLW, ISO, and QSR requirements required Working knowledge of US and OUS clinical research regulations and techniques required Experience with MDR, Vigilance, and other regulatory compliance programs required Demonstrated ability to effectively implement and manage complex global regulatory program Bachelors Degree in scientific or health related field. Masters Degree preferred Sr. Regulatory Affairs Specialist At least 5 years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, MHLW, TGA, and TPP 510(k), IDE and PMA experience (desired) Knowledge of FDA, EU, MHLW, TGA, and TPP requirements Bachelor’s degree in related fieldRegulatory Affairs Certification (desired)

5/7/2023 29

VP of QA/RA  (So. Cal) (ON HOLD) BA/BS/MS degree in quality science, engineering or related field 15+ years experience in medical device Currently operating at a VP level Quality Manager §          Minimum of B.A./B.S. degree in a technical or scientific field §          Minimum of 10 years experience working in the medical device industry §          Demonstrated success in a start-up, entrepreneurial  work environment §          Thorough knowledge of FDA Quality System (cGMP) requirements, ISO 13485:3003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and Medical Device Directives (MDD) requirements §          Software quality experience required Sr. Quality Engineer BA/BS engineering discipline 5+ medical device experience  Experience in statistics and data analysis Complaint handling experience is a must Senior Quality Engineer BS degree in Engineering, Physical or Life Sciences is required  Minimum of five years of Quality Assurance experience in the medical device industry.  Experience with FMECA and/or other risk management tools Experience designing and installing quality process sampling systems, procedures and statistical techniques ********************************************************************

For further information please contact:Bonnie GothmannVice President, Executive SearchCorporate Search415-296-9692 X 106bonnie@corpsearchjmi.comSenior Medical Writer-San Francisco Area (posting Jan. 26)I am looking for a Sr Medical Writer to work full time.  The position is in house, however telecommuting options may be available in the future.  It is a collaborative environment that has energy! Company

Small public company that is well funded!Marketed productsStable and in growth mode Position

Sr Medical WriterResponsible for writing clinical documents

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Assist with generation of Regulotory Submission Documents Must-Haves

BS, MS, or Ph.D. (scientific or medical field is a plus)Minimum 5 years in the Biotech/Pharmaceutical IndustryHas worked on at least one NDA submissionHas written CRF's Ideally a self-starter who can "hit the ground running"!_____________________________________________________________________Associate Director/Director of Medical Writing—San Francisco Area (posting Jan. 26)I am looking for an Associate Director/Director, Medical Writing.  This is a full-time, in-house position.  Given the economic times, they are one of my few clients that are doing well.  $$$$, marketed products and hiring!!  The Medical Writing group is respected and regarded as the experts.  The Associate Director/Director of Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff and is responsible for departmental resource planning, contributes to submission planning for program and product development, represents Medical Writing in communications with regulatory agencies, and may participate in review and approval of regulatory submission documents and publications.  MS or higher degree preferred; scientific focus desirable. Responsible for up to 5 medical writers and 1 project coordinator as functional reports.  Up to 2 Medical Writing Managers as direct reports and may manage the writing efforts of contractors. For further information please contact:*****************************************************************************If interested,Please contact Patti.Patti Henderson-O'ConnellPresident/OwnerO'Connell Search International17106 Vose St.Lake Balboa, CA 91406818-675-6465

I have a new opening for Surgi-Vision in Irvine. Electrical EngineerBS or MS up to 160K depending on experience--must have Medical Deviceand RF experience--- MRI and Catheter experience a plus. Very strongTechnically. Please let me know if you would be interested or know ofsomeone who may beSend Resumes to Thomas SchmidEmail Tom@bluechipsearch.comPhone 877-258-7724 ext 105

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Position Location: San Francisco

Thomas SchmidSenior RecruiterOffice: 760-547-2177 ext 105Toll Free: 877-258-7724Fax: 877-231-9771

www.bluechipsearch.comhttp://www.linkedin.com/in/tschmid949

Director, Business Development / Sales Our client is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. The company meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.   Currently, we are experiencing significant growth and are conducting a search for sales candidates in the San Francisco area. Reporting directly to the Senior Director within our Business Development Department, the Business Development Director's primary responsibilities will include the following: ·        Building and executing business plan for achieving quarterly and annual revenue and pipeline objectives ·        Identification and prospecting of new business leads, including qualification and needs assessments ·        Presentation and positioning of marketing and sales solutions to prospective client executives (outsourced professional services) ·        Developing effective proposals and persuasively closing new business opportunities ·        Maintaining client relationships and building new business relationships ·        Management of territory and named accounts ·        Strategic ability to identify needs and problem solve for clients ·        Coordination with regional director, project teams, and team leads/project managers ·        Coordination with business groups for staffing and proposal/project development ·        Identification of up-sell opportunities ·        Provide lead generation and RFP generation The successful candidate will have a combination of the following skills/experience: ·        Living in SF/Bay area (preferred) ·        BA/BS degree required (Business or Life Science related degrees preferred) ·        Minimum of 5-7 years professional experience selling software and/or services into the Life Science Industry (Pharmaceutical, Biotech, Clinical Research) ·        SF.com knowledge a plus ·        Knowledge of all MS Office applications required ·        Excellent written and oral communication skills ·        Self motivated determined individual with a track record for success ·        Strong sales skills & ability to work with CXO-level executives

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·        Willingness to travel up to 100% The company is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities. The entrepreneurial setting, coupled with our financial stability, has made them an employer of choice, and one of the most sought after Life Sciences employers in the area. ContactJarboe & Associates janetjarboe@qwest.net(office) 970-669-2600 970-689-2962 (mobilenot listed - OPPORTUNITIES FOR MEDICAL DOCTORS - please call for details_________________________________________________________________________________Senior Scientist lll– Clinical Pharmacokinetics (full description available soon-please contact) TexasRequires a Master's and 9 years of experience or a PhD and 6 years experience. Must be familiar with and very comfortable with NONMEM, simulation, PK modelingAssociate Director / Clinical Team Leader, Clinical Pharmacokinetics Texas

Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis. Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives. Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products.Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives. Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies. Submits and administers employee performance standards and actively develops personnel within the team.Provides timely and quality documents (i.e., protocols, clinical study reports (Scars), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects. Represents Clinical Pharmacology at various clinical meetings and project team meetings.Principle Responsibilities:Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives.Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.Provide effective and timely mentoring and support for subordinates.

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Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.Additional (enhancing) skills:Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation. Familiarity with relevant company SOPs and document management systems. Good knowledge of GCP requirements. Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. Excellent written and oral communication skills._________________________________________________________________________________Associate Director, Regulatory Affairs__________________________________________________________IllinoisResponsible for representing the department on project teams, and collaborating on the development of regulatory strategies (e.g., NDA/BLA strategy) with management oversight; driving submission related activities and successfully executing regulatory strategies. Responsible for significant interactions outside the Regulatory Affairs department on complex issues including interaction with regulatory authorities.Position Requirements: *Bachelor's degree in scientific discipline; advanced degree preferred. *At least 8-10 years industry experience, 6 years in Regulatory Affairs preferred. *Recognized as experienced in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope. *Scientific knowledge in chemistry, general biology/physical sciences, or health sciences, and ability to apply knowledge to regulatory issues and pharmaceutical product development and to deal with in-depth technical information from a variety of disciplines. *Comprehensive knowledge of the drug development process and life cycle management and application to current and evolving regulatory requirements associated with assigned products and therapeutic/technical areas. This should also include experience with global regulatory projects. *Strong organizational skills with the ability to manage multiple complex projects in a matrix environment. *Excellent written and verbal communication skills. Ability to communicate effectively with peers, technical experts, scientists, senior staff, and regulatory authorities to present scientific/regulatory case and foster high degree of credulity with regulatory authorities *Experience managing others preferred.___________________________________________________________________________________Clinical Program Manager (Anemia)____________________________________________________ CaliforniaDescription:*Reporting to the Associate Director, manage the implementation of clinical studies to ensure that they are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines *Coordinate and oversee the internal activities for each study in terms of clinical, data management, biometrics, drug safety, regulatory, and clinical supplies activities *Write clinical trial protocols and amendments *Manage the preparation of Informed Consent Forms *Assist in the design and development of and approval of Case Report Form development *Coordinate team review of tables, figures, and listings *Working with Clinical Contracts and Outsourcing, select service providers, review and approve of site and service provider budgets and scope of work Oversee management of service provider activities including CROs, contract regional CRA monitors, data management, biometrics, central and specialty laboratories, and IWRS/IVRS *Address and seek resolution of administrative issues with investigational sites or service providers. *Escalate

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issues to the Associate Director as needed *Manage service provider budgets and invoices *Directly manage in-house CRAs in terms of administrative and project performance *Forecast and manage the investigational product needed for the conduct of clinical trials *Manage and ensure investigational product accountability *Develop clinical monitoring plans and establish study monitoring priorities *Develop and maintain cross-functional study timelines using MS Project *In partnership with the Associate Director, Medical Monitor, Biostatistician, and Drug Safety, assist in the preparation of Clinical Study Reports, product Investigator Brochure, IND Annual Reports, expedited or annual safety reports Job Requirements:A minimum of 7 years of experience as a CRA in a pharmaceutical or biotechnology company with the first five years of progressive CRA responsibilities and at least the last two years in a management role *Knowledge of FDA regulatory requirements and competence in ICH/GCP guidelines *Knowledge of clinical trial methodology *Demonstrated proficiency in the implementation, maintenance, and closure of clinical trials *Demonstrated managerial and supervisory skills Demonstrated ability to work effectively with cross-functional project team members (regulatory affairs, QA, marketing/business *development, research, project management, etc) *Excellent written and oral communication and analytical skills *Demonstrated experience in managing international studies; experience with East Asia a plus *Computer proficiency in MS Word, Excel, Project, Power Point, and Outlook; MS VISIO a plus Education:Bachelor's degree in a scientific or health-related fieldLanguages:English - excellent command of English, written, oral and in presentationsMandarin – Ability to speak, write and type a plus _________________________________________________________________________Senior Clinical Contracts Associate_________________________________________________________CaliforniaResponsibilities: The Senior Clinical Contracts Associate's primary responsibilities shall include but are not limited to the preparation, negotiation, tracking and finalization of the clinical trial agreements and confidentiality agreements inclusive of the site budget within the clinical trial agreement. This position reports to the Associate Director, Clinical Contracts and Outsourcing. Specific duties Draft and track status of clinical trial agreements, amendments and confidentiality agreements with site specific information and e-mail to sites Status the sites regarding outstanding agreements and budgets, and provide weekly updates to clinical team Process all agreements for execution, ensuring that the appropriate departments within company receive a copy Ensure that all budget approvals, correspondence, invoices and fully executed contracts are filed within the clinical contracts filing system and ensure files are audit ready Track all fully executed clinical agreements and invoices Update the financial spreadsheets for each study/site Liaise with clinical for monthly site accruals Pay, track and reconcile all payments to investigator sites Responsible for the development of site budget templates from the Schedule of Assessments Negotiate directly with the sites regarding budgets and contract language Liaise with legal for review of contract language Mentor Clinical Contract Associates and may have a supervisory role Ability to

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negotiate global clinical trial agreements and budgets Ability to establish, draft and train with respect to process documents Requirements: BS/BA in Business Administration, finance or related discipline, or equivalent education plus experience At least four (4) years of site budget and contract negotiation experience Minimum of 5-7 years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR) Excellent negotiation and written/verbal communication skills Ability to work independently, creative thinking and problem solving skills Ability to understand the full clinical development process Must understand the "Sponsor of Choice" philosophy Must have good organization and planning skills, proven ability to handle multiple priorities and work independently Must be a team player and be a leader within the department Proficiency with MS Word, Excel, Access and Outlook required_________________________________________________________________________________Senior Clinical Research Associate_____________________________________________________ ___California The Sr. Clinical Research Associate (CRA) will be responsible for initiation, monitoring and other tasks associated with clinical studies. The Sr. CRA will also be responsible for investigational site management for clinical studies and will assist in the creation of an implementation of protocols, informed consents, case report forms, clinical study reports and related study materials. He/she will also provide guidance, clinical trial management and direction to contract CRAs in the field. Responsibilities: The Senior CRA will actively participate in clinical trial activities from study start through closure Assist the CPM with vendor management, including the CRO (monitoring and data management), central laboratory and IVRS vendors Work with CRO and manage site selection process Assist with reviewing and editing study documents such as Study Operations Manual, Study Drug Manual, Project Management Plan, Communication Plan, Monitoring Plan and Data Management Plan Prepare and review study tools such as Source Document Worksheets and Source Data Verification Worksheets Assist with protocol development, study design completion and designing CRFs Accompany CRO/CRAs to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols Order and coordinate study supplies Develop and maintain tracking tools Assist with CRO selection and management of CROs and other vendors May assist with site budget negotiations Plan and participate in investigator meetings Assist and support data validation and data clean procedures Assure regulatory compliance of investigational sites with SOPs and FDA and ICI guidelines Requirements: BS in Life Sciences or health-related field Minimum of 5 years experience as a CRA including monitoring of sites and in-house CRA study management Minimum of 2 years in-house experience Some experience in protocol writing and informed consent development Experience in study site selection, site budget development / negotiation and overall site management Some experience in vendor (CRO, central laboratory, IVRS, EDC) selection and overall vendor management (CROs and preferably IVRS) Willing to travel as needed (Minimal travel)_________________________________________________________________________________(Senior) Clinical Program Manager (Fibrosis) California

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My client seeks a Clinical Program Manager / Sr Clinical Program Manager for our Connective Tissue Growth Factor (CTGF) Fibrosis Program, to manage trials for subjects with diabetic nephropathy and chronic kidney disease who will enroll into our developing FGCL-3019 (monoclonal antibody) program. Reporting to an Associate Director, specific responsibilities include: Manage clinical studies to ensure that they are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports Manage study sites and train clinical site staff to ensure protocol and regulatory compliance. Responsible for clinical site budget development Responsible for CRO selection and assist in the development of RFPs. Manage the Contract Research Organizations (CROs) responsible for the conduct of clinical studies Manage the activities of vendors, including clinical services, data management, biostatistical services, and central laboratory services Manage clinical personnel, including in-house and contract Clinical Research Associates (CRA) May be responsible for ensuring SOP and regulatory compliance of staff Assists in CRO selection, development of RFPs, budget negotiations, and provides CRO management overall. Assists in the development and writing of study protocols, study plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA). Interact with investigators and thought leaders for protocol development, presentations and publications. Coordinate and participate in investigator meetings. Mentor and develop junior staff. May manage and direct junior staff Estimate and manage the clinical supplies needed for the conduct of clinical trials Develop clinical monitoring plans and establish study monitoring priorities Address and seek resolution of administrative issues with investigational sites and/or CROs Requirements: Bachelor’s degree in a relevant scientific discipline or equivalent. 8+ years of relevant clinical experience in the pharmaceutical industry or equivalent. Knowledge of GCP and ICH guidelines required. Proficiency in the implementation, monitoring, and management of clinical trials Demonstrated managerial and supervisory skills Excellent communication and interpersonal skills. Detail oriented. Able to problem solve and use good judgment. Able to work within a team. And work with general instructions. Proficiency with MS Word, Excel, Outlook, and PowerPoint. Microsoft Project skills preferred. Must be willing to travel as required for the project (approx. 10%)Clinical QA, Sr. Specialist / Clinical QA, Manager_______________________________________________ColoradoRequirements:BS in biological, life sciences, or equivalent experience. 3 years experience in GCP QA for Sr. Specialist, 5 years experience in GCP QA for Manager. Additional experience in GLP and/or GMP QA, a plus. The ability to travel up to 25%. Excellent diplomatic, analytical and communication skills, both verbal and written. Detail oriented with proven organizational and leadership skills.Independently determines and develops approach to solutions. Work is reviewed upon completion for

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adequacy in meeting objectives.Must be proficient in Word, Excel and PowerPoint. Description:-Responsible for evaluating the compliance of clinical trials conducted by company to US FDA regulations and ICH guidelines, as well as corporate policies and standard operating procedures.Responsibilities:-Support Clinical Research Department by evaluating Clinical Study compliance with FDA Good Clinical Practice regulations and ICH guidelines through internal and external audits.-Plan, conduct and report GCP audits of clinical investigators, vendors, systems, and key reports and documents. Monitor audit responses and corrective action to assure accuracy and consistency.-Participate in development and review of GCP QA SOPs and review of other SOPs & forms supporting company’s GCP activities. -Participate in the planning, developing, delivery and documenting of comprehensive GCP training programs to company personnel involved in or supporting GCP activities. Assist in development and delivery of GCP training materials at Investigator Meetings.-Represent GCP QA on appropriate clinical study teams to facilitate audit planning and timely GCP advice, as directed by GCP QA Management.-Facilitate regulatory inspections of company facilities and provide appropriate support for inspections of company’s clinical sites and vendors, as needed.-Implement and maintain appropriate CQA files of all audit and inspection activities-Keep CQA Management apprised of compliance and personnel issues through periodic reports.-Maintain good working relationships and communication with GCP QA customers including Clinical Development, Regulatory Affairs and company GXP QA staff.Regulatory Affairs Programs Mgr / Sr. Reg Affairs Programs Mgr_________________________________ColoradoRequirements:BA/BS degree in a scientific/health sciences discipline 5-7 years experience in pharmaceutical Regulatory Affairs (title will be determined by experience)Experience in the management and preparation of regulatory agency submissionsExperience working with regulatory agenciesAbility to communicate effectively (written and verbal) and adapt to a changing environmentDescription:We have 2 openings for either a Regulatory Affairs Program Manager or a senior level Program Manager. These positions will report into Regulatory Affairs within the Clinical Development department and will have interaction with preclinical, clinical and chemistry, manufacturing and controls personnel. Responsibilities:• Participating in the development and implementation of regulatory strategy for one or more projects and ensure successful regulatory filings. • Working in a team environment and planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registration.• Representing the department on multidisciplinary product development teams.• Assessing and communicating regulatory requirements for clinical, preclinical and CMC submissions and programs to assure that all development activities are in compliance with applicable the US and pertinent international regulations and guidelines. • Coordinating and supporting the writing of INDs, Canadian CTAs, IMPDs and ROW

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investigational applications with an emphasis on Phase 1 and Phase 2 development stages. Must be “hands-on” and willing to take on projects and tasks to support project teams.• Serving as the primary contact with regulatory agencies and CROs and facilitating communication between the agencies and project teams. • Attending and/or chairing agency meetings. • Writing regulatory agency meeting minutes and assisting in the preparation of briefing documents.• Ensuring timely submission of appropriate regulatory documents individually, as a regulatory team, or through contract organizations.• Maintaining compliance with regulatory commitments.• Working efficiently and effectively within regulatory teams, fostering collaborative exchanges, teamwork, and mentoring of colleagues. • Managing, prioritizing and dividing tasks to ensure all submissions are on time.• Writing regulatory SOPs and ensuring SOPs are in compliance with current regulatory requirements.• Working with Regulatory Operations to develop submissions in electronic and legacy format.Early phase (I II) experience, Experience with IB's and protocols, CMC helpfulAssociate Director/ Director - Ocular Drug Delivery___________________________________MassachusettsRequirements: Ph.D., MS or Bachelor’s degree in Pharmacy, Chemistry, or related field, advanced degree preferredMinimum of 5-10 years experience in formulation development in the pharmaceutical or biotechnology industry, with ophthalmic formulation experience highly desirable.Working knowledge of applicable GMPsA history of creative problem solving in the formulation area.Excellent written and verbal communication skills and presentation skills.Previous management experience in a laboratory environment with formulation CRO management highly desired.Ability to work effectively in a dynamic team environmentJob Responsibilities and Accountability:Assist the Core Project Team in the determination of overall drug development strategy, through in depth understanding of the formulation requirements and technical constraints Design of formulation development plans for ophthalmic and non-ophthalmic drug delivery, including pre-formulation, process development and validation, and clinical trial material manufacturing Management of formulation development plans including compliance with time lines and assigned budgetCommunication of all formulation-related information including strategy, progress against plan, timing and budget issues to Core Project Team and Management Team.Identification, evaluation and contracting of required external formulation expertise and capacity, to meet strategic development goalsAct as the primary communication point and manager of all contracted vendors in the formulations area Oversee the design and planning of all experiments, and supervise contracted formulation scientists, including review and finalization of technical reports with assigned vendors. Development and manufacture of all formulated drug for clinical (GMP) and non-clinical (GLP and non-GLP) use

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Responsible author for drug product CMC sections of all regulatory submissionsDevelop analytical methods and stability protocols required for the characterization and stability testing of drug products.Remain current in GMPs and commit to Company’s Quality Policy in related areas. Facilitate technical transfer of drug product manufacturing processes from formulation development to manufacturing vendors/CROs.Other duties as assigned._______________________________________________________________________________________________Senior Scientist lll– Clinical Pharmacokinetics (full description available soon-please contact) TexasRequires a Master's and 9 years of experience or a PhD and 6 years experience. Must be familiar with and very comfortable with NONMEM, simulation, PK modeling________________________________________________________________________________________________

Associate Director / Clinical Team Leader, Clinical Pharmacokinetics Texas

Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis. Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives. Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products.Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives. Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies. Submits and administers employee performance standards and actively develops personnel within the team.Provides timely and quality documents (i.e., protocols, clinical study reports (Scars), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects. Represents Clinical Pharmacology at various clinical meetings and project team meetings.Principle Responsibilities:Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives.Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.

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Provide effective and timely mentoring and support for subordinates. Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.Additional (enhancing) skills:Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation.Familiarity with relevant company SOPs and document management systemsGood knowledge of GCP requirements. Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. Excellent written and oral communication skills.Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.

Medical Director, Medical Affairs Responsible for: the development of P3b/P4 studies and medical monitoring for SL studies; enhancing scientific relationships with key opinion leaders; reviewing promotional and educational material for accuracy; leading consultant and advisory meetings; and reviewing grant applications for scientific merit. Responsibilities will also include ensuring strategic alignment among functional groups within Medical Affairs; regular interactions with senior product and clinical management for strategic development issues and marketing operations; and contributing to life-cycle management. This person will contribute as a medical director to product specific and therapeutic area functions such as publications, medical information, medical education, and consultancy and advisory boards. This person will be responsible for development of post-marketing clinical development plans including design of P3B, P4 studies. They will assist the commercial team in development and communication of consistent global and regional brand messaging across indications. They will provide technical scientific/medical consultation to the commercial team to ensure accuracy and compliance with Astellas standards. They will help to develop phase IIIb/IV clinical trial needs and strategies to support brand. They will assist in the development and execution of brand publication strategies. Effective performance of activities requires minimal supervision or guidance by the Vice-President of Medical AffairsM.D. degree, Board Certified or Board Eligible in Designated Specialty (preferred) or a PhD with subject matter expertise in Urology or ImmunologyPosition RequirementsMinimum three years clinical or clinical research experienceMinimum one year experience in the pharmaceutical industryExcellent communication and presentation skills, strong interpersonal skills.Strong clinical research/medical affairs background, and excellent problem solving abilities.Demonstrate abilities to work effectively in a team environment.Ability to interpret and evaluate clinical data. Leadership skills and ability to effectively manage projects and timelines. Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development. Knowledge of FDA, other regulatory agency and professional requirements, regulations and guidances

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Able to work independently on all aspects of assigned projectsExcellent organizational skills

Sr SAS Programmer Responsible for providing all required SAS programming functions. Responsible for working with project statistician to design tables, listing, graphs, and statistical summaries. Responsible for coordinating all programming activities for assigned projects. Responsible for completing quality assurance and validation procedures on assigned SAS programs. Responsible for developing SAS applications using higher level SAS features.Codes, tests and documents the development of SAS programs that generate output in conformance with defined specifications of tables/listings/graphs and other programs as assigned by manager.Creates study databases following the study database specifications as directed.Performs quality assurance checks and validation of SAS programs and prepares documentation of results.Serves as the lead programmer/analyst on assigned projects and co-ordinates activities of all SAS personnel on the project.Develops, modifies, test, validates, and documents SAS Macro procedures for standardized tables and graphical summaries.Runs programs and prepares program output for reviews and study reports.Reviews statistical analysis plan components (IAP, TLG shells, DDR, etc).Participate in the creation of study database specifications with project statisticians.Creates and tests programs for the import and export of SAS datasets.Participates on multidisciplinary project teamsWorks with Data Management personnel to develop SAS programs that aid in the data review and editing activities.  Minimum requirements are: MS in Statistics, Biostatistics or equivalent experience and at least 3 years experience using the SAS system to summarize clinical trial data, or a BA degree in a quantitative field or equivalent experience and at least 5 years SAS programming experience in a clinical trials environment. Candidates must demonstrate thorough knowledge of SAS by successful completion of the SAS core certification test for version 6 SAS (SAS Certified Professional V6) or an equivalent means.  

Susanna ChauSuperGen Investor Relations Managerschau@supergen.com email925-560-2845 tel

SuperGen, Inc.Clinical Research Associate/Sr. CRA"Work for a company that is making a difference in the fight against cancer". SuperGen, Inc. (www.supergen.com) brings together high tech and biotech to search for new, more effective drugs for the treatment of cancer. We are looking for a motivated, dedicated talented team to change the current paradigm of drug discovery and development. This candidate will be working in the Corporate Office

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located in Dublin, California – just a 10 minute shuttle ride from the Dublin-Pleasanton BART station.This position will be responsible for management of a global clinical trial. Selected candidate must have experience managing a Contract Research Organization (CRO) and coordinating the work of Regional CRAs.

Partnering with the medical monitor, clinical staff, and other departments, he/she will ensure the clinical trials are conducted in accordance with corporate Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable federal and national regulations (FDA and EMEA).

Designs, plans and implements the overall direction of clinical research projects. Draft and participate in the development of relevant documents for Phase 1 through 3 studies including protocols, informed consents, CRFs, study manuals, monitoring plans, data management plans, abstracts, presentations, and manuscripts and clinical study reports.

Assist in the preparation and finalization of corporate SOPs.

Assist in the preparation of safety, interim and final study reports and resolving data discrepancies.

Assist in compilation of investigator brochures, under close supervision.

Monitor (able to perform site visits for data collections, source data verification, and review of regulatory documents/files, if applicable) or Co-monitor with CROs, regional monitors as required.

Assist in site selection, study implementation and ongoing management of study sites either directly or via vendor/CROs, if applicable.

Participate in evaluating study drug supply requirements and managing logistics.

Manage CRO/Vendor relationships.

Coordinate and/or participate in Investigator meetings.

Interact with investigators in protocol development, presentations and publications.

Train study coordinators, vendors and investigators regarding Good Clinical Practice/ICH and SuperGen, Inc. processes.

Participate in the development of best practices for Phase 1 through 3 study management.

Requires minimal direction to determine methods and procedures on new assignments.

Travel up to 25%.

Benefits:

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We provide a comprehensive benefits package to include medical, vision, dental, short and long term disability, group term life, 401(k) and an Employee Assistance Program.

******************************************************************************************

From: Nikita Manalo [mailto:Nikita.Manalo@onassignment.com]

Sr. R& D Engineer6 month Contract5-10 years of Medical Device experience. Strong Statistical Knowledge,experience with JMP Software, MathCad, and Solidworks. Experience withValidation and Verification of Medical Devices required. Santa Clara___________________________________Quality Engineer - New ProductsContract to Hire3-5 Years of Medical Device experience. Strong Quality background desired with the ability to assist with Quality Assurance Support and New Product Development Programs. Validation and Internal/External Audit experiencepreferred. Mountain View___________________________________________Sr. Manufacturing EngineerDirect HireMin 5 Years of manufacturing engineering experience, preferably in a catheter based regulated environment. Experience with Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process FailureMode and Effects Analysis (FMEA) required.Sunnyvale

The following position is through a recruiter. Please respond directly to Danif interested and qualified.

Dan MillerLeading Edge Medical Search, Inc.www.LeadingEdgeMedical.com303.449.9300 Ext. 2

Manager/Director of Electrical EngineeringEssential Duties and Responsibilities include but are not limited to:* Provide continuous engineering support on existing products to maintain and improve margin, performance and quality. * Participate to the development of the product plan and departmental budget.

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* Manage R&D Managers and Engineers. * Work with General Managers and CTO to assess new product and technology opportunities. * Manage day-to-day activity for R&D Engineering for Instrument groups. * Staffing for product development and process engineering * Manage Electronics and EMI Labs. * Train and develop product development employees * Responsible for Design, Development and Process Engineering of all new electronic products. This activity directly reports to the CTO. * Responsible for overall systems compatibility for all new products that interact with an existing electronic components. * Responsible for Design and Development of Energy Based Devices. This activity reports directly to the General Manager for the Business Unit. Education and/or Experience:Essential. B.S. in electrical engineeringAt least 10 year of experience of technical experience in relevant field (EE in medical device, RF generators, .) and at least 4 years of management experience.Must have knowledge of electrosurgical power supplies. Excellent leadership and motivational skills.Desirable: M.S degree or Ph.D. in related technical area. Experience in Electrosurgical RF generator design and electrosurgical devices. . If you meet therequirements, please contact Abhishek Banerjee @ abanerjee@saccinc.com .PROJECT MANAGER -APL – REGULATORY, AffymetrixRequisition #: 3578

This position is key to driving execution on Affymetrix's product development efforts. Project managers will work within Affymetrix’s established phase gate product development process, typically as Core Team Leaders, to drive projects to meet schedule, quality, COGs, product feature, and cost deliverables. Successful candidates must be capable of working collaboratively with project “Core Team” members from various functions (particularly Product Marketing and Development leads) to successfully drive new product concepts to market under extremely aggressive timelines in a dynamically evolving technology environment. Many of the applicable programs have complex system integration elements, so comfort with integrated systems is required.

Key responsibilities:As Core Team Leader, the candidate will be accountable for execution on project timelines and overall program goals from initial concept through successful commercialization. The Core Team Leader drives general project management including:• Development of project contract including project schedule and deliverables.• Analysis of project risks and maintenance of project schedule.• Schedule and chair Core Team meetings.• Ensure all aspects of project are covered, assign project deliverables.• Prepare meeting agendas, publish meeting minutes, ensure all required project documentation is generated and archived (including but not limited to project definition, project plans, risk analysis, financial analysis, market analysis, technical documentation, monthly progress reports, presentations,

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technical reviews, organization readiness reviews, etc.)• Primary liaison between all teams and departments involved in the product development/delivery process to resolve issues, facilitate tradeoff decisions, and remove obstacles. The Core Team Leader plays a key role in identifying and resolving or escalating resource conflicts/gaps.• Collaboration with project Core Team Members (particularly Product Marketing and Product Development team leads) to prepare and present phase-based project approval review materials to senior management on Affymetrix’s Product Approval Committee (PAC).• Analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.• Responsible for compliance of project records with appropriate regulatory guidelines.• Interfacing with internal and external regulatory compliance groups for project audits, both pre- and post-product launch. Position Requirements

• Bachelor's (B.S./B.A.) or advanced degree, preferably in a scientific/technical discipline (biology, molecular biology, chemistry, etc.).• Documented and certified QSR, GMP/GLP or other regulatory training.• Direct experience with managing assay, reagent, instrument or software development projects directed at regulated products.• Minimum of 5 years of experience combined between program/project management and product development and commercialization, preferably in a life sciences/biotechnical industry. • Project management skills – experience in successfully managing large and small multi-disciplinary team projects using standard project management tools. • Knowledge of standard product development cycle (theoretical) and the actual process (practical application).• Experience with the Core Team Model and as a Core Team member.If you meet these requirements, please contact  reza islam [ rezadeshi@yahoo.com

If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .

Sr. Quality Associate—CV Therapeutics A Bachelor’s degree in the sciences (biology, chemistry, analytical, bio-analytical chemistry, or chemical engineering) with a minimum of 7 years of pharmaceutical experience in a GMP quality (QA/QC) environment. Good working knowledge of Quality Systems and GMP standards. Knowledge of European regulations is desirable. Detail-oriented with excellent review skills of product records for lot disposition. Problem solving and analytical skills as well as technical writing abilities. Ability to reconcile more complex issues independently. Ability to organize and manage multiple tasks in a fast-paced environment. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e. Microsoft Office products).  This position is to provide quality assurance support for CVT’s commercial and clinical programs.• Review and approve master batch records, labels, product specifications and other pre-production documents for compliance to FDA and international health agency requirements.

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• Review executed production batch records and analytical data related to lot release and associated documentation including any deviation and investigation reports.• Review and approve stability protocols, data packets and study reports • Maintenance of electronic databases (Scientek) and paper archives (lot history records, reports, logbooks).• Write, revise and review standard operating procedures.• Review product development reports, protocols and labels.• May review and approve validation protocols and final reports.• Interact with contractors to resolve lot release or validation issues.• Assist in review of CMC sections of regulatory submissions.• Up to 20% of travel may be required.If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .Mgr, Regulatory AffairsEmeryville, CA--NovartisPlan and coordinate the preparation (and assist in the preparation, as necessary) and maintenance of regulatory submissions for U.S. and product registrations to applicable foreign regulatory bodies. Specifically, the duties will include management of various types of regulatory submissions: Biologics License Applications (BLA) and related Supplements and Amendments, Investigational New Drug Applications (IND), Export Applications, as appropriate by product and regulatory strategy and ex-US product registrations. In addition, this position will include direct involvement at the project team level in order to provide regulatory support for new product development and existing product lines. May have direct supervision of one or more Regulatory Associates as appropriate by project category. A minimum of a BA/BS in the biological sciences (with an emphasis on molecular biology, biochemistry, immunology, or related field). Advanced degree desirable. The ideal candidate should have at least 5 years direct relevant experience in a FDA-regulated environment including direct experience with in vitro diagnostic (IVD) products - regulated as biologics (FDA/CBER) or medical devices (FDA/CDRH). Knowledge of cGMP, QA/QC principles, and Quality Systems is also desired. Prior experience with computers (e.g., word processing and spreadsheets) is highly desirable. The candidate should possess very strong written, verbal, and interpersonal communication skills. Ability to work both independently as well as in close collaboration with multidisciplinary teams will be required. The RA Manger will report to a Director of Regulatory Affairs. The RA Mgr. Should have an understanding of the underlying regulatory strategy and background as related to as specific project. In addition, an adeptness and desire for problem solving and decision making in a cross-functional team setting are essential characteristics. The RA Mgr. must assume a lead role in the completion of projects, must be able to organize and prioritize work assignments, effectively manage time and available resources and work independently and closely with individuals of various responsibilities and educational levels throughout the company. The RA Mgr. must consider the overall impact of decisions as they affect other aspects of the business and will initiate appropriate actions as required. The position is a day shift position and will be based at the Chiron headquarters facility in Emeryville, CA

EOE Minimum Education Required Bachelors Minimum Experience Required 5-8 Years

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If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .Assoc Dir, Quality OperationsLocation: Emeryville, CAJob DescriptionLocated at our global headquarters in Emeryville, California, Novartis Diagnostics is constantly finding revolutionary ways to protect the blood supply, and diagnose and monitor patients. Novartis Diagnostics is actively transforming the landscape of disease prevention, diagnosis, and treatment with state-of-the-art nucleic acid testing and advanced molecular science. As part of Novartis Corporation, which has operations in 140 countries and on 5 continents; we provide a truly global environment. This means you will have more opportunities to advance your career and to make a real impact around the world.

Reporting to the VP, Quality Operations, the Associate Director, Quality Operations role will support global expansion activities to ensure quality procedures and infrastructure are in place to support commercial activities in compliance with Novartis quality standards. Additionally the position will be responsible for coordinating the Diagnostics Quality Improvement Projects (QIP) and Innovation, Quality, Productivity (IQP) activities, ensuring effective implementation of quality improvement initiatives globally.

Primary Responsibilities:  Attend Diagnostics Commercial Committee meetings and coordinate efforts for regional expansion.Coordinate quality activities between the regional offices, commercial operations, global marketing and the Diagnostics Quality Headquarters in Emeryville to support timely implementation of quality requirements.Support regional quality heads with Quality Manual implementation and mitigation of quality improvement remediation plansContribute to Material Review Committee (MRC) meetings to facilitate Third-Party supplier reviews, remediation and approvalCoordinate Diagnostics QIP global activities.Attend QIP and Bluechip team meetings, track commitments and timelines to ensure QIP implementation as plannedCoordinate QIP and IQP initiatives with regional Quality headsHigh level of impact on the Diagnostics business based on geographic expansion planning and ensuring the delivery of quality products. Supports our commitment to quality improvement and is highly visible throughout the division to coordinate our compliance with quality improvement initiatives.

Minimum requirements: Bachelor’s degree in Biological Sciences, Quality Management or related field.QIAS or QCPA, LEAN Six-Sigma desirableFluent English (oral and written) required withSpanish and/or Mandarin (oral) a plus.10+ years management experience in Quality operations in biotechnology, preferably blood banking, diagnostics, medical device or bio-pharmaceutical industries.

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Experience in a regulated GMP manufacturing environment is required.Strong analytical and written skills, proficient in MS Word and MS Excel softwareIn depth knowledge of FDA, ex-USA and ISO regulation requirements as well as standard Quality management tools and standards.Experience working with FDA licensed biologics including FDA inspections.Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.Individual must work in an ethical manner and ensure regulatory and Novartis Quality System requirements are followed.Experience with LEAN Six-Sigma; black-belt preferredThe position requires a strong understanding of global quality system regulations. Demonstrated experience leading quality improvement teams to successful measurable outcomes is required.Strong leadership skills and experience in leading diverse teams that are not direct reports Strong organization skills, with the ability to prioritize and get projects completed on-timeExcellent written communication and report writing skills;Strong cGMP background.Minimum Education Required-BachelorsMinimum Experience Required 8-15 Years

If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .Sr Manager, Quality Assurance  Palo AltoJob Description: OUR CLIENT seeks  a Senior Manager of Quality Assurance. This position is responsible for the management and maintenance of OUR CLIENT’s external and internal audit programs. DUTIES AND RESPONSIBILITIES:• Manage the cGMP vendor qualification program; apply risk based methodology to conduct and coordinate cGMP audits of contract manufacturers, testing laboratories, packagers and distribution centers • Manage and conduct both internal and external cGMP audits as a lead auditor.• Prepare audit agenda, execute audits and issue audit reports• Perform training needs assessment based on audit trends• Manage the CAPA program and conduct effectiveness assessments• Support the development and maintenance of quality systems such as Change Control and Deviations• Review and revise SOPs for consistency and compliance with regulatory requirements• Support regulatory inspections by FDA and foreign regulatory agenciesQualifications:• BS/BA in a scientific discipline and a minimum of 10 years of pharmaceutical experience• Must have a minimum of 5 years of direct experience and strong auditing skills in conducting and leading cGMP audits of API, bulk drug product, packaging facilities, distribution centers and testing laboratories

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• Must have strong working knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks• Experience with small molecule drugs• Excellent communication skills (both oral and written) and the ability to work collaboratively across departments• Strong attention to detail• ASQ or equivalent certification is highly desirable• Ability to travel up to 35%OUR CLIENT offers competitive salaries and an excellent benefits package, including stock options and an employee stock purchase plan. ****************************************************************************** 

********************************************************************************Here’s a new website dedicated to life science recruiting with listings in various sectors of our industry. Go to BeakerBeat.com and see if this site is helpful. BeakerBeat, has a weekly video webcast of everything life sciences; and claims 11,000 open positions and 200 video-enabled company profiles on their Beaker.com site.

And another new website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled PharmaExpo.com at http://www.epharmaexpo.com/job.php

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The South San Francisco Life Science Career Fair, Monday, March 9, 2009

Date and Time: March 9, 2009, 10 am to 4 pmLocation: South San Francisco Conference Center

The Career Fair is an opportunity for displaced biotech employees or life science students to meet company and industry professionalsThe life science industry offers jobs for all education and skill levels. Over 25 life science companies will be available to meet with youIn addition to looking for a job, visit our Wellness Room to learn how to take care of yourself in these economic times

Meet your local Workforce Board representatives who can provide you with resources and support you in your job search. Meet your Professional Organization for extensive networking opportunities.Get one-on-one resume review and advice (sign up on-site)Learn how to center and focus in times of stress (sign up on-site)Thinking of starting your own business, meet our Incubators

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For further information, please contact us at ssfcareerfair@gmail.comPlease register by Friday, February 27, 2009.To Pre-Registration, go to http://tinyurl.com/d5eha9*******************************************************************************

These job postings are listed on my blog accessed at www.audreysnetwork.com along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly.

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