Quality Control

Key Responsibilities

• Perform and document routine testing in compliance with cGMP requirements, including:

  • Potency testing of drug substance and drug product for release and stability
  • Potency comparability and non-GMP studies
  • Testing of manufacturing growth media components for raw material release

• Execute analytical methods, including:

  • qPCR (e.g., Minute Virus of Mouse detection)
  • ELISA (identity, residual host cell protein, residual DNA, residual Protein A)
  • cIEF (identity testing)
  • Biacore (identity and binding analysis)
  • SDS-PAGE and Western blot (identity and purity)

• Assist with assay development, optimization, and lifecycle activities as needed

• Method validation and transfer

• Critical reagent qualification

• Laboratory investigations and assay troubleshooting

• Operate, maintain, and troubleshoot QC laboratory equipment in a cGMP-compliant manner

• Execute routine assignments in accordance with approved procedures, escalating issues as appropriate

• Ensure compliance with safety, cGMP, CFR, and company policies through routine lab operations and safety checks

• Review laboratory SOPs and recommend improvements to ensure compliance with regulatory and corporate standards

• Revise SOPs and work instructions as assigned

Additional Responsibilities

• Participate in on-call response for environmental/chamber excursions, as required

• Support department self-inspections and may train as a Self-Inspector Auditor

• Assist with reference standard preparation/fills

• Train and mentor junior analysts

Education:

• Bachelor’s degree in a scientific discipline (e.g., Biology, Biochemistry, Chemistry, or related field)