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Senior Manufacturing Associate / Manufacturing Associate (512RM)

Company: Fate Therapeutics Inc
Location: San Diego
Posted on: January 16, 2022

Job Description:

Fate Therapeutics is seeking an experienced and highly motivated manufacturing technician to join our manufacturing team to support operation of the cGMP clean room suite in a variety of production activities related to Fates cell therapy clinical trials. The successful candidate will develop and adhere to written procedures (SOPs) related to housekeeping, monitoring of equipment and facilities, and manufacturing of cell therapies internally at Fate. This person demonstrates cGMP compliance and support for manufacturing activities across multiple programs. This is a full-time position initially reporting to the Associate Director, Manufacturing, and is located at our corporate headquarters in San Diego, CA.

  • Assists in setting up manufacturing areas and equipment/fixtures. Performs facility and equipment monitoring activities.
  • Writes manufacturing operating procedures that are technically sound, promotes effective and efficient operations, and complies with cGMP requirements.
  • Performs manufacturing and support operations described in standard operating procedures and batch records.
  • Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
  • Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
  • Completes training assignments to ensure the necessary technical skills and knowledge.
    • Bachelors in relevant science or engineering discipline, or equivalent in work experience.
    • Minimum 2 years of experience in cGMP biologics cell culture manufacturing, experience in biotech or cell therapy manufacturing preferred.
    • Experience in the following preferred:
    • Aseptic processing in ISO 5 biosafety cabinets.
    • Universal precautions for handling human derived materials in BSL-2 containment areas.
    • Cell expansion using incubators and single use bioreactors.
    • Cell washing processes and automated equipment.
    • Cell separation techniques and automated equipment.
    • Cryopreservation processes and equipment.
      • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
        Working Conditions and Physical Requirements
        • Will require working with cells and cell lines
        • Will require working with hazardous materials 100% on-site work at corporate headquarters in San Diego, CA
        • Evening and weekend work as necessary
          The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to Jobble

Keywords: Fate Therapeutics Inc, San Diego , Senior Manufacturing Associate / Manufacturing Associate (512RM), Other , San Diego, California

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