C = ContractCH = Contract to HireDP = Direct PlacementDOE = Depending on experience

Scientist II – CH – Sorrento Valley $45-70k+ FLIPR, Calcium cell based assays, GPCR, G proteins, 384, HTS , calcium and/or ion channels,

single transfectionQualifications:

B.Sc. or M.Sc. in biology and at least 2 industry exp. FLIPR Performance Expectations:

Bachelors in cell biology or biochemistry with a minimum of 2 years relevant industry experience in a HTS setting

Proven expertise with cell based signaling assays (i.e. GPCR cAMP and Ca2+ second messenger assays).

Documented experience with multimode plate readers and FLIPR instrumentation required Experience with engineered cell lines for GPCRs and ion channels highly desirable

Preferred Education and Experience Experience with database-based analysis software preferred Basic cell culture experience is a plus Experience with automated liquid handling workstations

Supervisory Responsibility This position will not have any supervisory responsibilities.

Work Environment This position operates in a BSL1/2 laboratory setting. There is potential for exposure to human

tissues and fluids.

Technical Support Representative (QC Tech II) – DP – Torrey Pines $45-65k DOE BS degree with (PCR OR QC) AND (GMP OR NGS) that wants out of lab 95% customer service/TSS, 5% lab Requires knowledge and skills normally acquired through the successful completion of a BS

Degree in a scientific discipline. 2-8 years of experience in a GMP-regulated industry or equivalent combination of education and

experience. Molecular Biologist to handle questions and emails

Data Entry Clerk x3 – C – Torrey Pines $15/hr Ideal BS degree, open to data entry and accessioning They prefer a non-degreed with exp OR a new grad with some Excel work. A good

communicator. If you send a new grad they need to have worked in an under grad lab and make sure the resume has excel and pipetting on it. They prefer molecular labs.

The job is mainly data entry – accessioning but could be some lab. Some labeling of tubes too.

Required: H.S. Degree / Diploma. Experience with data entry into a clinical database. Desired: Associates Degree in a biological field. The Data Entry Clerk is responsible for performing data entry into a clinical database. Performs basic data entry and filing functions for the clinical database to ensure that data is

accurately entered in a timely manner.

QC Analyst II – CH – Torrey PinesQC Analyst II x2 – DP – Torrey Pines

$16-25/hr DOE BS/MS Chemistry with HPLC experience. Ideally 6 months of industry exp. The purpose of the QC Analyst II is to carry out assigned laboratory duties which may include

sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products. In addition, will also participate in the development and validation of analytical methods.

2 years of relevant hands-on laboratory experience. BS degree in scientific discipline from an accredited college or university or equivalent

experience. Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc Good knowledge of cGMPs and laboratory practices. Proficient in the operation and maintenance of basic laboratory instruments such as HPLC and

GC. Excellent observation skills and problem solving abilities. Ability to follow analytical procedures and protocols. Good laboratory techniques. Conduct laboratory tests in compliance with established internal Standard Test Methods,

compendial and vendor/partner supplied methods. Maintain organized records of tests performed and results obtained following company policies Assist in performing laboratory investigations. Write investigation report as required. Maintain a level of technical knowledge and understanding in the assigned areas of responsibility

that are consistent with the current scientific requirements of the company. Understand and comply with all company policies, safety procedures, and SOPs, including

cGMPs and cGLPs Assist in the preparation of analytical data for internal and external meetings and presentations. Provide technical assistance and training to other laboratory personnel. Participate in the transfer of methods to/from the Quality Control department. Represent functional area in Project Teams, as required. Write documents for GMP compliance such as standard test methods, validation reports, and

SOPs.

Scientist I and Scientist III – DP – Torrey Pines $80-100k, $100-120k

Must have PhD, must have experience with: API’s, Pharma, HPLC, GC, LCMS, dissolution testing, analytical (method) development

Provide technical and analytical assistance to support new product development and manufacture of commercial products

Develop, evaluate (qualify/validate) new analytical methods Design, execute and interpret experimental results. Critically evaluate the experimental results of

all group members. Summarize findings for internal distribution/presentation (e.g. slide presentations, reports). Summarize findings in presentations, technical reports, and manuscripts for external distribution

and/or presentation. Write documents for regulatory submissions and/or review (e.g. INDs, NDAs, SOPs, STMs,

batch records, qualification and validation protocols and reports). Represent department at project team meetings. Provide team leadership. Coordinate project goals and tasks. Act as liaison with corporate

partners. Maintain high level of technical knowledge in areas of responsibility. Maintain good working knowledge of the use, maintenance and repair of laboratory and

manufacturing equipment. Supervise less experienced team members, where appropriate. Apply the knowledge, skills and experience obtained to increase efficiency in solving new

problems. Provide training and technical assistance to less experienced lab personnel. Comply with cGMPs where appropriate. Maintain cooperative working relationships with other departments (e.g. QC, QA, Formulation,

process development). Maintain good documentation and exercise clear, concise communication skills.

Bioinformatics – DP – Torrey Pines $85-105k Open to New PhD or someone in/out of post doc. R, Perl, Python, NGS data is ideal. Ideally

experience with oncologyEducation & Experience: Ph.D. or equivalent breadth of experience and understanding in Bioinformatics or related

scientific discipline. The Research Scientist 1, Bioinformatics demonstrates expertise in genomic analyses, preferably

with a research background in oncology and/or immunology. This scientist will support projects that aim (i) to identify molecular markers that are predictive of patient response following treatment with company’s propriety gene therapy technology and (ii) to characterize virus-host interactions, in patients’ tumors and cell culture systems. The primary responsibility of this position is to help program and analyze genomics data coming out of key clinical trials.

Duties and Responsibilities Include But Are Not Limited To: Develops and optimizes robust workflows for next-generating sequencing datasets, including

DNA and RNA sequencing. Identifies molecular features from genomics datasets that correlate with clinical outcomes.

Works on informatics problems of diverse scope, including novel genomics applications. Reads pertinent scientific journals and articles, maintains relevant current scientific awareness,

prepares written reports and in collaboration with other scientists, and writes original proposals for research projects.

Significantly contributes to defined documentation practices in support of regulatory filings, white papers, patent filings, publications, grants and other company documents.

Co-authors scientific papers and/or journal articles and present research results to colleagues at scientific meetings.

Desired Knowledge and Abilities: Expertise in analysis of human next-generation sequencing data and knowledge of best practices. Competency in informatics-related programming languages and interfaces such as Python, Perl, R

and Linux. Familiarity with publicly and commercially available bioinformatics tools. Requires knowledge of discipline including knowledge of protocols, scientific method and its

applications, and use of specialized equipment.

Analytical Scientist – DP – Torrey Pines $90-125k

JOB DESCRIPTION: Perform analytical bench work related to method development, optimization, transfer,

qualification, and validation to meet GMP requirements. Duties will also include writing the associated methods, protocols, and reports. Provide technical

analytical support to late-stage and commercial products. As a senior member of the lab staff, this position will also provide guidance, advice, and training

to junior lab chemists.REQUIREMENTS:

A degree in chemistry or a related scientific discipline and related GMP laboratory experience with a minimum of 7+ years with a BA/BS degree, a minimum of 4+ years with a Master’s degree, or a minimum of 3 years with a Ph.D. degree.

Experience with a wide range of analytical techniques including but not limited to HPLC, LC/MS, GC, physical testing methods, and compendial test methods relating to small molecules.

Demonstrated experience in independent method development. Experience with raw material/excipient/API qualification and testing. Working knowledge and experience with cGMP and ICH guidelines. Excellent analytical, technical writing and data management skills. Excellent oral and verbal communication skills. Flexible self-starter with the ability to work independently or with co-workers and multi-task

under aggressive development timelines. Preferred Qualifications: Experience working in a GLP environment and with analytical methods

such as GPC and viscosity to characterize polymers.ESSENTIAL DUTIES & RESPONSIBILITIES:

Conducts experiments requiring proficiency in a broad range of experimental techniques and analytical methods, including HPLC, GC, GPC, and various methods for polymer characterization.

Must have extensive experience with LC/QTOF and other mass spectrometric based hybrid techniques

Design and perform experimental studies to support regulatory filings such as identification of unknown degradants.

Performs method optimization, transfer, qualification, and validation at the bench to support new and existing projects.

Writes protocols for analytical method transfer, qualification, and validation and prepares detailed written reports of findings resulting from the execution of those protocols.

Participates in problem solving activities with staff in other departments at Heron and with CMOs and CTLs.

Provides technical support for products in commercial distribution. Conducts laboratory investigations on aberrant results as needed. Troubleshoots assays and equipment failures as needed. Ensures lab efficiency with on-time delivery of methods and results. Supports efforts of junior analysts.

CAR-T Scientist – DP – UTCTHIS DEPARTMENT WILL LOOK AT CANDIDATES WHO HAVE AT LEAST 1 YEAR OF

MAMMALIAN CELL CULTURE FOR OTHER LOWER LEVEL OPENINGS!!!!!! $DOE We currently have openings for R&D positions including Scientist, Postdoctoral Fellow, Research Associate/Technician in

chimeric antigen receptor engineered T cells (CAR-T) for cancer immunotherapy. These positions will be responsible for preclinical/clinical development of CAR-T cells for cancer immunotherapy, including chimeric antigen receptor construction, retroviral/lentiviral vector packaging, T cell culture and gene transduction, T cell functional assays, animal tumor model studies, and clinical trial patient biopsy specimen assays.

GMP positions including GMP facility manager, manufacturer technician, QC, and QA positions for retroviral vector or CAR-T cells GMP manufacturing.

THIS DEPARTMENT WILL LOOK AT CANDIDATES WHO HAVE AT LEAST 1 YEAR OF MAMMALIAN CELL CULTURE FOR OTHER LOWER LEVEL OPENINGS!!!!!!

QA Specialist – C – Torrey Pines $50-60k Must have GMP, come from pharma and have small molecule experience. Ideally want

chemist/HPLC that wants out of lab Education: Bachelor’s degree in science-related field is preferred. Experience: 1-3 years experience within the US pharmaceutical industry or equivalent. GMP background in solid oral products (tablets, capsules) with either experience in the QC lab or

in manufacturing preferred Familiar with a variety of the field's concepts, practices, and procedures, and the regulatory

framework within which the pharmaceutical industry operates. Essential Job Functions:

Performs document control functions such as change control procedure for documents (SOP’s, NCE’s, CAPA’s, MBR’s, and etc) and equipment

Plans and organizes daily activities. Assists with the training of others on GMP requirements and their application. Assist with planning, organizing and supporting a comprehensive vendor management program

which includes auditing the vendors. Provides support for manufacturing activities, such as production line clearances, production

record review, and review of other manufacturing documents. Performs analytical data analysis in accordance with procedures. Participates in internal audits, and assists in the resolution of internal audit findings. Assists in the materials management program, which includes assignment of material codes,

review and approval of raw material and packaging component specifications, and materials disposition.

Responsible for Equipment/Instrument Calibration and Maintenance Program, and relevant activities associated with this program.

Reviews and approves Equipment/Instrument Qualifications. Other duties as perceived and agreed upon by management.

Lyophilization Expert – DP – Torrey Pines $100k+ (will pay for relo if required*) This is an instrumentation expert, someone who will be the expert on staff, identify & buy

machines, calibrate them, etc. currently seeking a Sr. Lyophilization Specialist to join the Drug Product Manufacturing group as

the subject matter expert to implement new and existing client projects, train personnel, and drive continuous improvements for processes & equipment related to lyophilization of parenteral products.

Responsibilities: Interacts with clients to ensure successful technical transfer and integration of lyophilization

processes into Althea’s manufacturing department. Provides technical and theoretical support to manufacturing staff within area of specialty. Writes and reviews SOPs, compliance, change controls, risk assessments and other technical and

quality related documentation. Employs high level technical expertise to investigate and resolve complex matters related to

lyophilization equipment and processes. Responsible for continuous improvement to existing equipment and process procedures to

enhance safety, quality and productivity. Researches and implements new equipment, methods and technologies for the lyophilization of

parenteral products. Trains others on equipment and procedures associated with lyophilization. Coordinates & oversees the activities of all cross functional departments (Manufacturing,

Metrology, Validation and Quality) to successfully complete all projects. Assists with re-qualification and validation of equipment and procedures. Assists equipment specialists in the routine maintenance of production equipment as needed.

Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.

Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Requirements: Bachelor’s degree in Life Science discipline or equivalent. Minimum of eight (8) years of relevant experience in a parenteral manufacturing environment

with at least five (5) years in lyophilization. Experience operating and troubleshooting automated lyophilization, tray loading/unloading, and

vial handling equipment. Extensive knowledge of the processes and qualification for CIP, SIP, vacuum integrity testing,

media simulation and parenteral lyophilization. Demonstrated knowledge and experience with low temperature rotary screw refrigeration

systems, lyophilizer vacuum systems, helium leak detection, and the instrumentation associated with routine lyophilizer performance monitoring, functional control, and qualification activities.

Experience with lyophilizer loading/unloading using RABS and full isolator environmental barriers.

Demonstrated ability to understand and apply complex technical concepts to manufacturing/production methodology.

Must have a high level of knowledge in global pharmaceutical cGMP’s. Must be able to develop solutions to complex problems that require an in-depth degree of

ingenuity, creativity, and innovation. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Must be familiar with Microsoft Office applications.

CAPA Specialist – C – Sorrento Valley $35-47/hr Need at least 6 mos-1 year experience with CAPA’s PART TIME- working 8-5 on Tuesdays and Thursday, potentially Monday, Wednesday, Fridays

on 1/2 days. Approximately 20 hours/week Filling in for someone who is going to school Perfect Opportunity for someone who is in school and looking for additional work/experience! The CAPA Specialist II is responsible for ensuring the CAPA system is being managed

effectively as part of the CAPA Administration group. They must work well with others in the organization to ensure Quality System processes are compliant to internal and external requirements.

Preferred educational background: Bachelor’s degree in a related technical field is preferred but not required. Preferred experiential background: Must have at least 2 to 4 years’ experience working in a professional environment where

compliance was of vital importance. Knowledge of the QSR or ISO 13485 is a plus.

Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.

Knowledge of MS Office. Excellent organization skills – must be able to manage a large number of simultaneous projects Attention to detail – must have precision in their work, especially as it relates to understanding

and documenting complex quality issues Excellent writing skills – must be able to summarize complex issues in a clear, succinct, and

accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.

Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources throughout the organization

Excellent critical analytical skills – ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue

Lab Technician III – C – Sorrento Valley $18-22/hr 2nd or 3rd shift (or swing between both!!!)

Job Description: Performs technical tests and experiments for process engineering within R&D. Performs set up of processing equipment. Monitors, audits and provides guidance to line operators. Processes test runs and prepares records, charts, and graphs of results for presentation to

engineering to identify yield problems or test new products. Provides technical assistance to process development and engineering personnel. Performs a wide variety of laboratory tasks and experiments. May make detailed observations, analyze data and interpret results. Maintains laboratory equipment and inventory levels for laboratory supplies. May write experimental reports, summaries and protocols. May also be responsible for media preparation in the research and development area, including

experiments as required and outlined. May also develop and maintain record keeping for experiments performed. Performs limited troubleshooting and calibration of instruments. May perform glass washing.

Skills/Experience What type of previous education is REQUIRED for this position? Currently attending a college

or university and working toward achieving an AA/AS or BA/BS including laboratory coursework in biology, chemistry or related field.

What are the 3-5 MUST HAVES the candidates need to have for this assignment? Works well in a dynamic team environment, time management skills, attention to detail

Do you have any particular companies or industries that you would like the candidate to have previous experience in? Regulated GMP environment

QC Technician (1 st , 2 nd & 3 rd shift available!!!!!) – C – Sorrento Valley 1st shift: $16/hr: 8am-4pm 2nd shift: $17.60/hr: 2pm-10:30pm

3rd shift: $18.08/hr: 10pm-6:30am BS degree in sciences, MUST have some undergrad experience either in restaurants, retail or lab

work. NO research. GREAT ENTRY LEVEL ROLE – TOP MED DEVICE COMPANY! HS diploma is a minimum; BS in sciences is a plus. Experience in any lab environment,

especially pipetting, is a plus. Ideal candidates will have proven experience working in roles that require humility and grit, including but not limited to retail, restaurants, services, etc.

From hiring manager "I always like people that have successes demonstrated in customer service (foodservice/retail supervisors, etc especially)"

Skills Acquires job skills and learns company policies and procedures to complete routine tasks.

Experience Typically requires less than 1 year of related experience. These will all be device testers, 100% lab based, testing our products with Human Samples. The candidate needs to be very accurate on filling out paperwork and have/develop strong

pipetting skills. Must be willing to work with blood and blood products

QA Inspector – C – Sorrento Valley $16-19/hr Non degreed ideal, anyone with GDP or GMP experience in QA, Doc Control or Med Device

okay!Qualifications – Preferred educational and experience:

High School Diploma; or combination of education and work experience acceptable. Previous experience within a medical device or pharmaceutical environment is an asset. Proficiency in Microsoft Excel and Microsoft Word

Job Summary The Quality Assurance Inspector is responsible for review and approval of in process and final

product documentation to ensure that quality standards are aligned with existing specifications. The QA inspector will review Device History Records prior to release. This position requires a high level of attention to detail, as the Quality Assurance Inspector is responsible for strictly adhering to the organization's quality assurance policies, and identifying defects and or production errors in order to prevent these materials from entering the supply chain.

Training to Start: Monday-Friday, 7:30am to 4:00pm After training: Shift will be Tuesday-Saturday, 11:00am-8:00pm (Sunday and Monday off)

Tasks and responsibilities: Performs review of Device History Records and other documentation for compliance to

established procedures and Good Documentation Practices. Scans and maintains all Device History Records. Issues Certificates or Compliance and Certificates of Analysis for all Finished Good Lots. Approves the release of materials to next step in the process. Rejects subassemblies or finished products as required.

Documentation Specialist x2 – C – Sorrento Valley$20-30/hr

This role will support the QA department in specific document control activities. Specifics of the job are as follows:

Aid in writing, formatting and subsequent processing of documents (SOPs, MPs, RMS, Labeling) relating to the implementation of new products that are under design control.

Write/update procedures by using a template/feedback provided by a subject matter experts Initiate required forms to process the documents through an electronic or paper based document

management system. Communicate with extended team and vendors to ensure alignment of various document related

information (Part Number, Descriptions, Bill of Material Data, CofC or CofA Data).Preferred educational background:

Bachelor’s Degree in a biological science or engineering discipline or equivalent experience. Preferred experience:

1-2 years of Document Control experience in an FDA regulated environment, preferably medical devices and/or in vitro diagnostics.

Experience with revision control. Experience in a GMP type environment (production, lab) preferred. Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR. Experience with 21 CFR 820, ISO 13485.

Profile of qualified candidate: Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc. Demonstrates commitment to the development, implementation and effectiveness of Ameditech's

Quality Management System per ISO, FDA and other regulatory agencies. Understands and is aware of the quality consequences which may occur from the improper

performance of their specific job. Must be flexible and adapt to changes. Ability to multi task and set priorities independently. Must be organized and extremely detail oriented. Must be able work independently but comfortable interacting independently with various groups

within the company. Must be motivated and willing to take on challenges. Takes initiative to problem solve and communicate with extended team members. Proficient in MS Word/Excel. Experience with Document Control databases such as Ensure, Agile, ect. Strong communication skills. Ability to work in a fast paced environment.

Lab Technician I x2 – C – Sorrento Valley $14-16/hr NON-DEGREED ideally! Someone who is okay working with samples, ideally with

medical/clinical background. The main function of a lab technician is to perform routine medical laboratory tests for the

diagnosis, treatment and prevention of disease. A typical lab technician may work under the supervision of a medical technologist.

Education/Experience:

High school diploma or GED required. Associate's degree in medical technology or vocational training preferred

0-2 years of experience requiredSkills:

Verbal and written communication skills, attention to detail, and problem solving skills. Basic ability to work independently and manage one’s time Basic knowledge of the information and techniques needed to diagnose and treat human injuries

and diseases Basic ability to analyze data and accurately document and record results

Job Responsibilities: Set up, adjust, maintain and clean medical laboratory equipment. Analyze the results of tests and experiments to ensure conformity to specifications, using special

mechanical and electrical devices. Analyze, gather and record test data to issue reports that use charts, graphs and narratives. Obtain specimens, cultivating, isolating and identifying microorganisms for analysis. May examine cells stained with dye to locate abnormalities. Consult with a pathologist to determine a final diagnosis when abnormal cells are found.

Scientist (5726) – C – Torrey Pines $30-35/hr TOP PHARMA COMPANY

Summary/Scope The Protein Homeostasis Thematic Center of Excellence (PH TCOE) is seeking a highly

motivated Senior Associate Scientist with experience in immunology and immuno-oncology-based assays to participate in drug discovery research with a particular focus on protein homeostasis as it applies to the Immuno-Oncology field. Emphasis will be in primary human immune cell biology assay development in the context of tumor microenviornment.

The successful candidate will work collaboratively in a multi-disciplinary environment to design and execute in vitro studies to further our understanding of the immunomodulatory effects of our novel compounds.

Responsibilities will also include development of primary cell and cell-line based co-culture assays to support target validation, mechanism of action, and biomarker selection. Experience with developing high-throughput screening assays a plus. The responsibilities further include routine profiling of novel compounds in cell-based assays across several research programs.

The successful candidate will have the opportunity to work closely with discovery project teams and scientists across the PH TCoE functional areas and to present his or her work at project team meetings and to the senior research leadership.

Skills/Knowledge Required: Bachelor’s degree in a scientific discipline with at least 8 years industry experience or Master’s

degree with at least 5 years industry experience. Practical experience in, and a solid understanding of basic cell biology, immunology/immune-

oncology, and assay development.

Extensive experience with mammalian cell culture (primary cells and cell lines) using single cells and co-culture cell models. Experience using single compound treatment and combination treatment studies is essential.

Expertise with a variety of cell-based assay technologies including antibody-based detection methods (e.g. Western, ELISA, immunoprecipitation), cell imaging (immunofluorescence, Incucyte, Cellomics), cell phenotyping technologies (e.g., flow cytometry) and functional assays such as cell cycle and apoptosis

Experience with molecular biology techniques such as RNAi and/or CRISPR, RT-PCR, and lenti-viral work is a plus.

Experience with the use automation instruments is a plus. Excellent communication, presentation, collaboration and organizational skills are required as

well as the ability to independently design, execute, and trouble-shoot experiments through completion.

Data analysis skills and experience with a variety of scientific software applications are required. The successful candidate will be an ambitious self-starter, be motivated to apply his/her skills to

meet diverse project needs, and enjoy working in a fast-paced dynamic team environment.

Research Associate (5725) – C – Sorrento Valley $25-30/hr TOP PHARMA COMPANY

Role/Responsibilities Analysis and purification of a range of samples using an array of HPLC/MS instrumentation in

the time-frame that is needed to provide results to the project. Perform high throughput purification of small molecule libraries. Perform HPLC method development independently. Troubleshoot and maintain HPLC, HPLC/MS, UPLC/MS, and other analytical instrumentations

routinely. Assist at building new laboratory informatics tools. Will be expected to prepare and complete organized and clear data reports for project. teams. Will be working in a multi-disciplinary and fast-paced environment.

Skills/Qualifications: The successful candidate must have: Minimum 4 years of expertise in the field separation sciences with emphasis on analytical and

preparative HPLC, HPLC/MS technique. Extensive experience in HPLC and Mass Spectroscopy method development. Working knowledge of modern analytical and purification methods. Experience with small molecule, regio- and diastereomer separation and purification. Strong knowledge of troubleshooting HPLC,HPLC/MS, UPLC/MS, and other analytical

instruments. Experience with chiral chromatography and high-throughput assays are a plus. High level computer skills required. Expertise with analytical instrumentation is required (Waters, Agilent and Shimadzu analytical

and preparative HPLC and HPLC /MS, Tecan, Genevac). Familiarity with MassLynx, OpenLynx, Chemstation, LC Solution is desired.

Excellent organizational, communication, and interpersonal skills is desired. In addition, we are looking for a scientist with a positive attitude with excellent collaborative and Team-oriented skills.

Be able to manage and deliver on several project deadlines concurrently. BS in chemistry or analytical chemistry is required with a minimum 4 years of analytical

laboratory experience in the industrial setting. *Mgr is willing to consider PhD level candidates if they possess the requirements of the job.

Technical Writer (5623) – C – Torrey Pines $30-39/hr TOP PHARMA COMPANY – MUST HAVE ACTUAL TECHNICAL WRITING

EXPERIENCE Responsibilities will include, but are not limited to the following: Preparation of pharmacology and cell biology reports for regulatory filings. Formatting reports in accordance with company style guides. Will work closely with senior scientists to provide high quality drafts for editing and will be

responsible for report completion. Knowledge/Skills/Abilities (KSA's):

Bachelor's degree required. 3+ years of writing experience. Science writing experience.

Associate Process Group Chemist – CH – Sorrento Valley $16-19/hr 6 months exp. outside of coursework. BS/MS okay. Chemist or Biochemist okay. The Associate Process Group Chemist, in accordance with forecasted requirements and

assignment, participates in the Chemistry Manufacturing department via: Manufacture products within QSR and ISO regulations Review/reconcile documents and work orders Support assigned projects with supervision Support departmental troubleshooting and process improvement teams Participate in product transfers May write/revise documentation with supervision May train lab technicians Display improving working knowledge of business processes as they relate to manufacturing Maintain daily adherence to Production goals relating to MUV/LUV, labor utilization, work order

closure, and schedule adherenceEducation and Experience

B.S./B.A. Life/Applied Sciences or equivalent experience and a preferred minimum of 6 months related work experience in a GMP environment.

Knowledge/Skills Basic algebraic, statistical and mathematical skills General computer knowledge Good organizational skills

Laboratory skills, such as protein purification, antibody conjugation, solution preparation ELISA experience, assay development skills, etc. Good verbal and written communication skills Good interpersonal skills Knowledge of QSR’s and ISO 9001 Knowledge of experimental design

ESSENTIAL FUNCTIONS: Manufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices,

controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices /procedures and schedules.

Support departmental troubleshooting and process improvement teams. Support cross-functional projects and training.

Reviews completed Device History Records and performs financial review of work orders. Reports on variances to supervisor.

Carries out all duties in a professional manner and in compliance with established business practices.

Manufacturing Supervisor x2 – DP – Carlsbad $70-85k Must have 5+ years in manufacturing, must have experience directly supervising 5+ employees.

Can come from any type of company – just must have supervisor/management and manufacturing experience.

The Supervisor provides leadership and technical support to the manufacturing organization. In this role, you will assist in development of, drive and achieve departmental short and long-term goals enabling the manufacturing organization to achieve New Product Development, Continuous Improvement, Quality, Compliance and Operational objectives.

Essential Duties and Responsibilities Supervise production personnel and activities to effectively meet forecast, customer demand,

R&D and New Product Introduction requirements. Develop and execute manufacturing training plans to ensure proper resources and talent are in

place to support manufacturing requirements. Develop production schedules in alignment with forecast and customer demand. Develop, implement, analyze, summarize and report key performance indicator data and metrics

for areas of responsibility. Responsible for identification of root cause and implementation of sustainable corrective actions for missed targets.

Responsible for ensuring compliance to quality systems (FDA, GMP, QSR, ISO), product specifications, process instructions, safety requirements and company policies.

Responsible for identification, resolution and follow-up on manufacturing issues that may arise. Responsible for identification and resolution of non-conformances via NCR and CAPA process

including initiation, root cause analysis and implementation of sustainable corrective action. Collaborate with and provide manufacturing input and support to New Product teams, including

the design for manufacturing (DFM) guidance, input on process / tooling development and developing/refining manufacturing instructions.

Develop and sustain the manufacturing team as a quality minded culture driven by focusing on customer service (external and internal), outstanding compliance, continuous improvement activities that support business objectives.

Supervisory Responsibilities Up to 30 non-exempt personnel, additional exempt and/or non-exempt personnel as required B.S. degree in Engineering or Science, or AA degree plus 5 years supervisory experience in

medical device, pharmaceutical or similarly regulated environment, or High School Diploma plus 7 years supervisory experience in medical device, pharmaceutical or similarly regulated environment

A minimum of 10 years of manufacturing experience in a medical device, pharmaceutical or similarly regulated environment.

Skills – Technical Working knowledge of quality system requirements (QSR), good manufacturing practices

(GMP), ISO and FDA regulations. Experience with a clean room environment including development and implementation of

environmental procedures. Working knowledge of manufacturing/MRP systems (QAD preferred)

MLT x5 – DP – San Diego $60-65k 4-5 openings for Medical Laboratory Technicians – ALL DIRECT HIRE!

QUALIFICATIONS Bachelor's degree in Medical Technology, Biology, Chemistry or related field. CA MLT License Experience in Chemistry, Hematology, Immunology (Point of Care Urinalysis) 1 - 3 years or more of related generalist experience. Immunology testing experience preferred. Basic computer literacy ability to comply with department needs and expectations.

PRINCIPAL RESPONSIBILITIES Independently perform laboratory procedures and tests necessary for the diagnosis and treatment

of patients per physician’s orders. Responsible assuring the accuracy of test systems and results prior to releasing such results.

Follow quality control procedures. Provide input on procedures. Use or operate clinical laboratory instruments and equipment in the collection, processing,

description, and analysis of specimens. Troubleshoot and perform maintenance on laboratory equipment. Maintain inventory of laboratory supplies. Maintain logs and order supplies. Work from broad policies and on general objectives using broad exercise of discretion and

independent judgment with respect to matters of significance within the HQ or mobile lab. Contribute to a safe and secure environment for patients, visitors, physicians and co-workers by

following established safety standards and procedures; complying with legal regulations. Maintain patient confidence by keeping laboratory information confidential. Serve and protect the clinical community by adhering to professional standards, clinic policies

and procedures, federal, state, and local requirements, and Clinic standards.

Enhance laboratory services and clinical reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

Maintain compliance with all company policies, quality systems, and procedures. Perform other duties as assigned by supervisor.

QA Specialist – CH – Carlsbad $TBD

ESSENTIAL DUTIES AND RESPONSIBILITIES Lead or co-lead client audits and inspections and provide support during regulatory inspections Perform external vendor and contract service provider audits, including scheduling, conducting

opening and closing meetings, issuing audit reports and verifying CAPA plans are implemented Assist in identifying medical device/ drug regulations for various geographies Facilitate quality system improvement programs and initiatives Review and approve GMP documents such as executed batch records, validation protocols and

reports, SOPs, and change controls to ensure compliance Assist in FDA and USDA regulatory submissions Assist in management of risk assessments, complaints, CAPAs and NCMRs, perform trend

analysis and maintain quality databases May require up to 10% travel

QUALIFICATIONS Requires a High School degree with a minimum of 3-5 years related quality assurance experience Experience working in the pharmaceutical and/or medical device or other highly regulated

industry is required Good knowledge of applicable regulations and guidance documents for human blood products

and medical devices, including ISO 9001;2015, ISO 13485, FDA QSRs, European regulations, and USDA regulations for animal serum

Knowledge or experience in risk management Experience with clean room operations is a plus Excellent communication and technical writing skills Excellent attention to detail, strong organizational skills with ability to execute assignments under

minimal supervision Computer literate with good working knowledge of Microsoft products (ERP experience is an

added advantage)

QA Document Control – CH – Sorrento Valley $20-22/hr, can go up to $32/hr for perfect match! This person will be auditing the training program to make sure everyone is up-to-date on their

training modules, matching up personnel with correct training program, scanning batch record documents, reconciling lab notebooks, and working with quality systems.

Assist/support Quality records management activities Scanning, filing, and inventory/archiving of Batch Production Records off-site Lab notebooks: issuance; retrieval; reconciliation; scanning; archiving Quality Records: retention; filing; destruction per Records Retention Schedule/Policy

Assist/support with the Controlled Document System Maintenance and monitoring of the Controlled Document System Process and issue new/revised/obsolete documents Provide internal customer support on electronic document management system Scanning, filing, maintenance and archiving of controlled documents Issuance, retrieval, reconciliation, scanning and filing of laboratory notebooks Assist/support the Training Program: Preparation with the on-boarding of new employees and training files Provide internal customer support on the learning management electronic system Administer training courses Maintenance and monitoring of the Training Program Maintenance of training-related employee records (training syllabus, job description, new

employees, promoted employees, terminated employees, etc.) Assist/support internal and partner audits related to document control and training programs Pharmaceutical or Biotech industry candidates A bachelors’ degree is preferred but can be substituted by an associates’ degree or high school

diploma and equivalent relevant experience Minimum of 2 years’ industry experience Alternate combination of education and experience will be considered Excellent problem solving skills, analytical thinking, and visionary skills necessary to grow a

company are of major importance Excellent command of the English language Effective verbal and written communication skills, and ability to effectively interact with

employees in a team-based environment Ability to learn quickly and dedication to complete required tasks The ability to obtain a thorough knowledge of and to operate to the company’s operations,

policies, and procedures in a short period of time. Ability to prioritize workload, to meet deadlines and to maintain high level of quality and

accuracy Initiative, resourcefulness and attention to detail Ability to prioritize multiple requests based on own judgment of importance/need to the

department Ability to work without specific instruction. Independent decision-making is a fundamental part

of the job and occurs regularly Attention to detail and decision-making skills to respond to high-pressure situations Must possess a thoroughly professional and positive image at all times and a solid work ethic Confidentiality of data requires extreme sensitivity and all disclosures require discretion

TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office

machines, or ability to be trained. Software Knowledge: Windows, MS Office (Outlook, Word, Excel), SharePoint.