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Genefab

Posted 7 months ago

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Bioprocess Specialist - CONTRACT

Alameda, CAOn-siteContract

AI Summary

The Bioprocess Specialist II executes upstream and downstream cell and gene therapy manufacturing in a GMP cleanroom, ensuring on-time batch delivery, troubleshooting, documentation, training, and continuous improvement collaboration.

About this role

The Bioprocess Specialist II plays a critical role in the cell and gene therapy manufacturing processes at GeneFab. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.

Responsibilities:

  • Technical proficiency in aseptic techniques working with manufacturing equipment/instruments in open and closed systems 
  • Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standards
  • Accurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP).
  • Work as part of a team to support the execution of daily GMP manufacturing activities.
  • Train staff in processing methods, aseptic technique, and cGMP clean room operations.
  • Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices.
  • Initiate and support the closure of Deviation Reports and CAPAs
  • Other duties as assigned by management.

    • Qualifications:

  • Minimum High School diploma or equivalent experience is required. Associates or higher degree in Biology, Life Science, or Engineering is preferred.
  • 3-4 minimum years of experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environment.
  • Familiarity with cGMP standards and basic understanding of Good Documentation Practices.
  • Proficiency working in cGMP cleanrooms and aseptic techniques
  • Advanced understanding of pipetting and micro pipetting.
  • Demonstrated ability to identify, challenge, and implement potential improvements to work procedures.
  • Ability to work flexible hours, including nights and weekends, as schedules may shift in this start-up environment.
  • Ability to stand for extended periods and lift up to 20 pounds.
  • Strong communication and teamwork skills, with a willingness to learn.

    • Skills

    Aseptic TechniqueBatch RecordsCAPACell And Gene Therapy ManufacturingCGMPCleanroom OperationsDeviation ReportsPipetting

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