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  1. Technical Associate - R&D

    BioGenex is seeking a Technical Associate to work as part of the Research & Development team to ensure that revenue and customer satisfaction goals are met.      KEY RESPONSIBILITIES Work with R&D to develop product line extensions and product improvements. Perform research on market requirements for current and future products. Assist in developing product packaging and content for collateral materials. Perform Quality Control tests Prepare documentation of results and help in ...

  2. Regulatory Affairs Project Manager

    Primary Job Function As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The ...

  3. REG AFFAIRS PROJ MGR - (14000005T6) (RK) A

    REG AFFAIRS PROJ MGR - (14000005T6) (RK) A Pharmaceutical / Biotech  Legal - Regulatory / Compliance Law Full-time United States - California - Santa Clara Jobs ID - 1040501 The Compensation Benefits - Full Bonus Eligible - Yes Interview Travel Reimbursed - Yes Detailed Job Description Job Description REG AFFAIRS PROJ MGR(Job Number: 14000005T6) Primary Job Function  As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, ...

  4. Quality Control Analyst

    A highly distinguished pharmaceutical corporation is currently looking for a Quality Control Analyst to work in Emeryville, CA.   This position will be responsible for supporting final product, stability, validation and R&D testing in a GMP setting.   Perform GMP support functions and assays, such as reagent preparation, chemistry assays and protein assays Conduct routine tasks to support the review and release of final product following established procedures. Complete tasks assigned on ...

  5. Assoc. Pharmaceutical Scientist I  R&D – Contract (SF Bay Area)

    DESCRIPTION: Responsible for manufacturing product(s) in a lab setting following standard operating procedures. Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products. Responsible for Batch Data Records, notebooks, customer reports and work order documents. Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating ...

  6. Engineering Technician – Contract (San Francisco Bay Area)

    Engineering Technician – Contract (San Francisco Bay Area) 73G4864 DESCRIPTION: Performs maintenance, testing, troubleshooting, calibration and repair on a variety of manufacturing and testing Instrumentation. Carries out routine repairs on a daily basis. Provides technical support to internal customers on operational or maintenance aspects of system equipment. Works independently and prioritizes work schedule of service calls a majority of the time, may require direction from Lead or ...

  7. Scientist Research and Development

    Job Id # 54185 Scientist  Research & Development Location: Pleasanton, CA Length: 6 Months Description: Responsibilities: includes but not limited to the following: • Plan, execute and document research experiments, analyze and present data • Perform nucleic acid extraction, and quantification from Whole blood, Plasma, buccal cells or other clinical samples. • Formulate simple and complex reagents, monitors laboratory supplies, and assures proper use and maintenance of lab equipment.  • Design ...

  8. Biosample Operations Manager

      Job Purpose: The Biosample Operations Manager (BOM) plans and coordinates all operational activities required for the collection, delivery and assay of Biomarker Samples (Dx and PD) within a clinical study.  The BOM works closely with Scientists to execute exploratory and Companion Diagnostic biomarker strategy.  The BOM serves as a single point of contact on Protocol Execution Teams, Biomarker Subteams and with CRO partners on all aspects of Biosample operations.   Primary Responsibilities and ...

  9. Method Validation Scientist / 105276

     CONTRACT / 7-9 MONTHS ... COULD BE EXTENDED Responsible for developing, optimizing, and validating release, in-process, raw materials and cleaning methods in support of Grifols Diagnostic Solutions immunodiagnostic intermediates. This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods’ intended use(s) and comply with applicable ...

  10. 3986332 – Method Validation Scientist

      Responsibilities: Responsible for developing, optimizing, and validating release, in-process, raw materials and cleaning methods in support of immunodiagnostic intermediates.  This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods' intended use(s) and comply with applicable regulatory and company validation requirements   ...

  11. 3985834 – Scientist – QA

    Responsibilities: Serve as Quality Partner for local QARs, EQNCs, CAPAs and Trackwise entry assuring completion in a timely and compliant manner Review and approval of Clinical Validation Plans, Clinical Protocols and Clinical Reports Review and approval of local IQOQ protocols Review and approval of Design History Files including Design Protocols, Reports and Plans Provide assistance during audits of the Quality System and Clinical Operations Requirements: Bachelor's degree in ...

  12. 3981734 – Scientist I/II

    Responsibilities: Conduct and monitor laboratory experiments utilizing published procedures, and technical and theoretical understanding.  Makes recommendations to resolve problems encountered during experimental procedures.  Assumes responsibility for the accuracy, quality, and timeliness of experimental results.  Summarizes experimental results, and reviews conclusions with supervisor/project leader. Communicates results of experiments in the form of reports and presentations.  Keeps ...

  13. Lab Manager

    Harvest Technical Services is seeking an ESCC Lab Manager for our San Francisco Bay Area Biotech client. Duties              The ESCC lab manager has a unique opportunity to contribute to organization, efficiency, and higher productivity in the CLD Group. The lab manager will serve as a liaison between the ESCC researchers and equipment suppliers, maintenance/repair technicians, and will ensure that the laboratory equipment is properly calibrated and maintained. The lab manager will ...

  14. Research Associate 1 – 6 Month Contract (San Jose Area)

      DESCRIPTION:   Responsible for execution of in vitro and in vivo experiments, including tissue culture, apoptosis assays, biological assays, western blotting, molecular biology and animal tumor models and generally supporting preclinical project teams in screening new compounds in cellular assays. Tissue culture biological assays, molecular biology, western blotting, spectrophotometry and microscopy. Small animal tumor models.  Development/execution of in vitro and ex vivo cell based assays ...

  15. Scientist-QA- 3985834

    Job Details: Serve as Quality Partner for local QARs, EQNCs, CAPAs and Trackwise entry assuring completion in a timely and compliant manner Review and approval of Clinical Validation Plans, Clinical Protocols and Clinical Reports Review and approval of local IQOQ protocols Review and approval of Design History Files including Design Protocols, Reports and Plans Provide assistance during audits of the Quality System and Clinical Operations    Education: Bachelor's degree in Biological ...

  16. Quality Assurance Specialist

     Direct Hire! Bay Area Biopharmaceutical company is seeking a qualified, highly motivated individual for the position of Sr. Specialist, Quality. Essential functions include but are not limited to the following: •Perform QA data review on in-process, release and stability reports •Perform or assist with batch data trending and reporting to facilitate writing of annual reports •Review and route GMP specifications for approval •Oversee the initiation and completion of Change Controls •Assign and ...

  17. Scientist II-3986763

    Job Duties Responsibilities: includes but not limited to the following: Plan, execute and document research experiments, analyze and present data Perform nucleic acid extraction, and quantification from Whole blood, Plasma, buccal cells or other clinical samples. Formulate simple and complex reagents, monitors laboratory supplies, and assures proper use and maintenance of lab equipment. Design and evaluate real-time PCR primers/ TAQMAN probes; optimize PCR amplification parameters for SNP ...

  18. Inside Sales Representative

      The Account Manager within Inside Sales will demonstrate and sell our clients' diverse and extensive line of consumables, apparatus and small equipment to life science research laboratories at academic, government, and biotech accounts. This includes working with existing named accounts as well as prospecting for new customers, qualifying leads, and training customers after the sale. This individual will work as part of an integrated sales team, both Inside and Field based, with specific product ...

  19. Application Scientist in Single Cell Genomics

    The Single Cell Application Specialist will serve as a technical resource for Product Managers, R&D Scientists and global field support teams to ensure Fluidigm’s success in the single cell genomics (SCG) market. The primary responsibility of this role is to conduct proof of performance studies, complete competitive testing and analysis and develop educational tools for single cell genomic applications. The Single Cell Genomics Application Specialist will manage the confirmation test site program, ...

  20. Documentation Specialist-3976784

    The Position A position is available for a Documentation Specialist I or II in the department of Global Development – Development Documentation Group. The successful candidate will process Design History Files and Design Changes in both hardcopy and electronic formats.  The candidate will also support Development Documentation responsibilities including the use of various software tools for records management, audit logistics, and facilitate staff requests and questions.   Responsibilities: ...

  21. Regulatory Affairs Specialist

    My name is Starr and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a prominent client of ours.  This position is located in Fremont, CA. Details for the positions are as follows:   Job Description:   Prepares and submits product applications (510(k), BLA, PMA or their equivalent in foreign markets. Respond to deficiencies and/or questions related to regulatory submissions. Represents Regulatory Affairs on product ...

  22. 3967384 – Scientist I/II

    Research Scientist I/II, working to develop molecular diagnostic assays. Microbiology – Growing pure bacterial cultures under BSL-2 (or lower) conditions. Molecular Biology – PCR, cloning, plasmid and genomic DNA purification, sample preparation methods, sequencing and sequence analysis. Complete Biosafety training, and perform all procedures in compliance with established Biosafety protocols. Document all work on worksheets and in electronic lab notebook.  Follow appropriate SOPs and fill out ...

  23. Scientist I or II- 3967384

        Position   Research Scientist I/II, working as a member of the Infectious Diseases team to develop molecular diagnostic assays. Microbiology – Growing pure bacterial cultures under BSL-2 (or lower) conditions. Molecular Biology – PCR, cloning, plasmid and genomic DNA purification, sample preparation methods, sequencing and sequence analysis. Complete RMS Biosafety training, and perform all procedures in compliance with established Biosafety protocols. Document all work on worksheets and ...

  24. Scientific Associate, Compound Management-3957746

    Job Description: The Lead Finding Platform (LFP) is looking for a highly motivated individual to be a key contributor in the Compound Management Group. As a member of the CMG, the successful candidate will be responsible for the receipt of incoming proprietary compounds, fulfillment of requests for distribution compounds and the operation of associated laboratory automation systems. Key Functions: Perform Compound Management tasks such as compound dissolution and aliquoting, manual transfer and ...