Quality Control Bioassay Specialist

1 month ago


Woburn, Massachusetts, United States Digital Prospectors Full time
Quality Control Bioassay Specialist

Our client is seeking a Quality Control Bioassay Specialist to join their dynamic team. This position offers an exciting opportunity to contribute to cutting-edge AAV-based gene therapy programs within a GMP-compliant environment.

Key Responsibilities:
  • Evaluate and approve cGMP analytical data for release and stability testing using bioassay test methods such as mRNA expression, functional potency, and ELISA testing platforms.
  • Perform data integrity reviews (data verification) to support validation, qualification, and analytical method trending reports as needed.
  • Support routine Laboratory Operations including, but not limited to:
    • Review logbooks for reagent preparation, equipment, and critical reagent tracking.
    • Conduct weekly laboratory housekeeping walkthroughs.
    • Prepare reagents and perform cell passaging.
    • Author and support quality events including change controls, deviations, CAPAs, and OOS Investigations as required.
    • Author analytical method performance trend reports and other technical documents as needed.
Requirements:
  • Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry, or a related discipline.
  • Minimum of 5 years of industry experience in a similar role.
  • Proven experience in mammalian cell culture and biological methods, including immunoassays, cell-based assays, and quantitative PCR.
  • Familiarity with GMP and GLP environments is essential.
  • Experience with statistical analysis software (i.e., SoftMax or JMP) is preferred.

As a Quality Control Bioassay Specialist, you will be an integral part of our client's team, working closely with cross-functional groups to ensure the highest quality products. If you have a strong background in bioassay methods, mammalian cell culture, and GMP practices, we invite you to apply today.



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