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  1. Clinical Trial Mgr / CTM III / Full Time / SF Bay Area

    Our San Francisco Bay Area client has asked us to locate, qualify and present a Clinical Trial Manager with 5 years of experience (2 yrs oncology).  Candidate will be responsible for and/or assisting with the execution of Investigator-Sponsored Trials and Client-sponsored hematological clinical trials from protocol concept through clinical study report. Primary Responsibilities and Duties:•Coordinate with investigators and investigator sites . •Coordinate and/or participate in investigator meetings ...

  2. 3921970 – Process Validation Engineer III

      Responsibilities:                Review Stage 1 Process Design documents, including the Process Description and Parameter Justification Report Write and Review Stage 2 Process Qualification protocols and reports Review the following:   -FMEA reports -Process Risk Mitigation Plans -Process Criticality Assessments -Technology Transfer protocols and reports   Write and Review process validation plans, protocols and reports Assist in preparation and execution of process ...

  3. Manager, Data Analytics

    Current Need McKesson is seeking a  Manager, Data Analytics to work with internal and external customers to understand purchasing requirements, order behavior, contract setup, and pricing management.   Position Description The Manager,  Data Analytics will be lead the development and resolution of critical / urgent initiatives needed to support customer growth and generics expansion in the Retail National Account segment.   The Manager, Data Analytics will also serve as a proactive agent of ...

  4. Process Validation Engineer III

    Hello,   My name is Domenic and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Process Validation Engineer III position for a prominent client of ours.  This position is located in Emeryville, CA. Details for the positions are as follows:   Job Description:   Review Stage 1 Process Design documents including the Process Description and Parameter Justification.   Report Write and Review Stage 2 Process Qualification protocols and reports.   ...

  5. Process Validation Engineer / 105053

    CONTRACT / 7-9 MONTHS...COULD BE EXTENDED...GREAT OPPORTUNITY   Review Stage 1 Process Design documents including the Process Description and Parameter Justification Report Write and Review Stage 2 Process Qualification protocols and reports Review the following:   FMEA reports and Process Risk Mitigation Plans Process Criticality Assessments Technology Transfer protocols and reports   Write and Review process validation plans, protocols and reports Assist in preparation and execution of process ...

  6. Physics Manager

      As Manager, Physics Research and Development you will be responsible for managing the physics team within the Research Group, with a focus on the physics-related features of the CyberKnife System. You will direct the physical investigation and development of new devices and methods for improved therapeutic radiation delivery and new Quality Assurance tools and procedures, involving treatment planning, treatment delivery, medical imaging, robotics, and radiation dosimetry. This role requires a high ...

  7. Deviation Specialist - 105015

    Deviation Specialist, Commercial Manufacturing – 1 year contract Resolves investigations and deviations to meet lot release time lines. Performs a wide variety of activities to ensure compliance with applicable GXP requirements. Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operations. Writes and revises standard operation procedures. Conduct investigations related to manufactured products. ...

  8. Engineering Manager (large scale wet chemistry) (VS)

    WHEN WE RECEIVE YOUR RESUME, WE WILL SEND YOU A COURSE ON HOW TO BECOME AN INTERVIEW SUPERSTAR.  IT IS FREE BUT IF WE CHARGED THOUSANDS IT WOULD BE WORTH IT.   The Position Engineering Manager (large scale wet chemistry) (VS) Pharmaceutical / Biotech Engineering - Chemical Full-time United States - California - Silicon Valley/San Jose - Santa Clara  ID - 883826 The Compensation Benefits - Full Bonus Eligible - Yes Interview Travel Reimbursed - Yes Detailed Job Description Join the Microarray ...

  9. Associate Director of Regulatory Affairs

    The Associate Director of Regulatory Affairs reports directly to the Executive Director, Regulatory Affairs. This position coordinates departmental planning, manages multiple project teams and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. This position is responsible for managing submissions to FDA and other regulatory authorities for investigational and marketed products.  RESPONSIBILITIES:    Contribute to the development, review, ...

  10. Glassware/Autoclave Technician / 105022

    CONTRACT / 7-9 MONTHS..COULD BE EXTENDED..GREAT OPPORTUNITY MUST HAVE.... High school diploma (or GED equivalent) and some college coursework in the biological sciences (including laboratory coursework). A certificate in Biotechnology, Associate degree in Biology or Chemistry is preferred. Related experience may substitute for education.   Specific functional responsibilities: -Production Planning/Execution – -Work with the team member and area lead to complete schedule for cleaning/autoclaving ...

  11. R&D Manager - Microbiology - Germicides

    R&D Manager - Microbiology - Germicides World wide leader in the development and production of life saving medical products seeks an R&D Manager to oversee microbiological research and formulation work in the design and development of new and existing biocides, germicides, cleaners and other sterilization and infection control products.  The R&D Manager - Microbiology will: Direct compliance and risk-based evaluations, supporting technical teams in the development of new sterile products and ...

  12. Sr. Manager - R&D Chemistry - Disinfectant Cleaners

    Sr. Manager - R&D Chemistry - Disinfectant Cleaners Worldwide leader in the development of life saving medical products seeks a Sr. Manager R&D Chemistry     to lead a research and development team in developing new disinfection and sterilization cleaners.  The Sr. Manager of R&D Chemistry will have strong working knowledge of microbiology, biocompatibility, antimicrobial, disinfection and sterilization and will:   Lead cross functional teams in developing disinfectant and sterilization cleaner ...

  13. 3914925 – Glassware Technician III

      Requirements: Must have strong written and verbal skills. Must be able to work in a team-oriented environment. Must be creative, highly organized, self-motivated, perceptive, and innovative. Must have strong analytical and decision making skills. Able to make decisions with limited supervision.   Technical skills requirements   Must have experience in GMP manufacturing. Must have experience in FDA and ISO regulated environments. Must have adequate knowledge of reagent preparation ...

  14. Senior Product Analyst, Strategic Accounts - 84016

      Current Need McKesson is seeking a Senior Product Analyst, Strategic Accounts to perform data, inventory and financial analysis.  This role is responsible for supporting cross-functional business teams in developing, implementing, and managing analytical & operational processes, including the creation of decision-making & status reports, all of which are critical to support: 1) inventory management business solutions for strategic pharmacy customers; 2) special supply deals with manufacturers of ...

  15. Clinical Trial Mgr / CTM III / Full Time / SF Bay Area

    Our San Francisco Bay Area client has asked us to locate, qualify and present a Clinical Trial Manager with 5 years of experience (2 yrs oncology).  Candidate will be responsible for and/or assisting with the execution of Investigator-Sponsored Trials and Client-sponsored hematological clinical trials from protocol concept through clinical study report. Primary Responsibilities and Duties:•Coordinate with investigators and investigator sites . •Coordinate and/or participate in investigator meetings ...

  16. Laboratory Assistant, Biomedical Research, Part Time $13.00 per hour

    Our client is a division of an international pharmaceutical corporation.  They have an immediate opening for a motivated, flexible employee.  This position will be 8 hours a day, two days a week.   The specific days are to be determined.  If you qualify, we want to hear from you right away. This is a great opportunity to be a part of a growing corporation with future potential for additional employment   Job Title           Lab Assistant MUST HAVE RELIABLE TRANSPORTATION AND BE FLEXIBLE ON ...

  17. Quality Control  Projects

     Job description 1. Project Manager activities for design and technical phases of the projects for the team 2.Create user requirements for the project and work with area managers to confirm 3. Enusre timely completion of projects assigned. 4. Participate in assay transfer and assay validation 5. Perform equipment qualification / maintenance 6. Assure and apply GMP throughout operations 7. Coordinate with customers to support multi-site operational activities 8. Support internal and external audits ...

  18. Global QA Compliance Associate Director Medical Devices

      Position: Major Tasks Provide expert leadership in medical device regulations in an individual contributor role including: the ability to identify issues of significance, communicate complex issues to site leadership, provide multiple alternatives to the solution of complex problems and the ability to provide guidance in their implementation. Leads relevant medical device project planning and review meetings; communicating to senior leadership regarding program status and supporting final ...

  19. 3872278 - Laboratory Associate I, Purification Sciences

    Responsibilities:   Perform scaled down purification studies to support the development of new processes or to improve the existing manufacturing processes in addition to providing support for QC or Manufacturing deviations investigations. Working under moderate to high degree of supervision from Lab Manager and/or senior Associates II. Executing scientific protocols in a team setting using scaled down column chromatography operations and ultra/dia-filtration. Ensuring their own experimental ...

  20. QC Analyst

    QC Analyst (Contract position) Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs.   Essential Duties and Responsibilities: • Perform environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at the manufacturing facilities. • Use a variety of laboratory instrumentation and ...

  21. Associate Manager, Outsourced Manufacturing

    Specific Responsibilities and skills for Position : Actively manages Contract Manufacturing Organizations (CMO’s) for their assigned projects. Ensures all regulatory requirements are met in the manufacturing of bulk API.  Ensures availability of raw materials at contract manufacturing sites.   Manages transfer of new technology from Process Development to contract manufacturing sites.  Assists in the coordination and execution of departmental quality, business and technical audits of API and raw ...

  22. Clinical Trial Mgr / CTM III / Full Time / SF Bay Area

    Our San Francisco Bay Area client has asked us to locate, qualify and present a Clinical Trial Manager with 5 years of experience (2 yrs oncology).  Candidate will be responsible for and/or assisting with the execution of Investigator-Sponsored Trials and Client-sponsored hematological clinical trials from protocol concept through clinical study report. Primary Responsibilities and Duties:•Coordinate with investigators and investigator sites . •Coordinate and/or participate in investigator meetings ...

  23. Manufacturing Technician

    Long term Contract position. The Manufacturing Technician 2 is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible ...

  24. Vice President, Corporate Quality

    JOB SUMMARY: Oversees and directs the Corporate Quality functions.  Provides leadership for Corporate Quality organization.  Leads Quality initiatives and projects across company operations.  Provides direction for compliance initiatives and issues such as Regulatory Intelligence, GxP Training, and and all of Quality Shared Services.  -Carries out managerial responsibilities in accordance with the organizations policies, procedures and state, federal and local laws. -Leads the Corporate Quality ...