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manufacturing in San Francisco Bay Area

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  1. (Senior) Associate Manager CMC Regulatory – Full Time

    DESCRIPTION: Responsible for supporting the CMC regulatory strategy and coordinating the process for compiling CMC section of regulatory submissions. Reviews CMC documentation to ensures they meet regulatory requirements. Coordinates CMC regulatory  workflow between departments as well as CROs Coordinates and compiles CMC document packages and investigational drug shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs Assembles, coordinates and ...

  2. 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, ...

  3. 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 ...

  4. 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 ...

  5. 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 ...

  6. 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 ...

  7. Senior Product Analyst, Strategic Accounts

      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 ...

  8. Director, Regulatory Affairs, CMC – Full Time

      DESCRIPTION: Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and leading and coordinating the  process for compiling the CMC section of regulatory submissions. Work with cross-functional project teams to develop CMC regulatory strategy and ensure success of regulatory filings. Reviews CMC documentation to ensures they meet regulatory requirements. Represents RA CMC  at project team meetings and coordinates regulatory  workflow between ...

  9. Associate Director / Sr. Manager Clinical Supply Chain – Full Time

      DESCRIPTION: Ensures that all clinical trials have timely and adequate supply for administration to subjects. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. The AD role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, and return or destruction. Additionally ...

  10. Protein Purification Associate - 104892

    Laboratory Associate I, Purification Sciences – 6 month contract 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 ...

  11. 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 ...

  12. 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. ...

  13. 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 ...

  14. 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 ...

  15. 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 ...

  16. Manufacturing Bioprocess Technician

    Duties: Support the Manufacturing department by working effectively to meet department goals, objectives and tasks to achieve desired results. Responsible for completing assigned tasks which include cleaning, sterilizing, and prepping glassware and parts used in the manufacturing environment. Work with senior technicians and leads to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on shift needs. May also include stocking, ...

  17. 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 ...

  18. 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 ...

  19. 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 ...

  20. 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 ...

  21. 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 ...

  22. 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 ...

  23. Medical Device R&D Technician - Burlingame, CA

    Position: Medical Device R&D Technician (Catheter & Balloon Catheter Manufacturing) Facility Location: Burlingame, California Dynamic Multinational Medical Device Developer, Manufacturer and Marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products actively seeks a skilled and experienced Medical Device R&D Technician with Catheter and/or Balloon Catheter manufacturing experience to join our Burlingame, CA office. ...

  24. Medical Device Assembler - Burlingame, CA

    Medical Device Assembler (Balloon Catheter – BAV & TAVR) Burlingame, California 94010 Position: Medical Device Assembler (Balloon Catheter – BAV & TAVR) Manufacturing Plant Location: Burlingame, California 94010 Term & Duration: Long Term Full Time (40+ hours per week) Employment Opportunity Available Openings: 10 current immediate openings Work Shift: Flexible, several shifts available - Our facility is in operation 24 hours a day Compensation: Highly Competitive Hourly rate plus overtime ...