QC Analyst III — cGMP Biotech (Flow Cytometry & ddPCR)

Neurona Therapeutics

South San Francisco (CA)

On-site

USD 90,000 - 120,000

Full time

21 hours ago
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Job summary

Neurona Therapeutics in South San Francisco, CA seeks a QC Analyst III to support analytical testing for the clinical pipeline. The role reports to the Senior QC Manager and focuses on release, stability, and characterization assays, including flow cytometry, ddPCR, UPLC, and cell-based potency/viability tests.

The ideal candidate has 4–6 years in a cGMP QC lab, strong hands-on lab skills, and a track record of collaboration across QA, Assay Development, and Manufacturing to maintain regulatory

Qualifications

  • Bachelor’s degree in life science; advanced degree preferred.
  • 4–6 years of analytical laboratory experience in a cGMP biopharmaceutical QC environment.
  • Experience with Flow Cytometry, ddPCR, UPLC, and cell-based assays.
  • Working knowledge of cGMP regulations, ICH guidelines, and USP/EP standards.
  • Experience authoring deviations, investigations, and SOPs.

Responsibilities

  • Coordinate QC testing during active testing windows and support clinical manufacturing operations.
  • Lead and mentor QC personnel on analytical methods, instrumentation, and best practices.
  • Perform cGMP testing for in-process samples, drug substance, drug product release, and stability protocols.
  • Verify analytical reports, data, and associated GxP documentation for accuracy and regulatory compliance.
  • Participate in investigations of deviations, CAPA implementation, and lifecycle management with QA and Assay Development.

Skills

Flow Cytometry
ddPCR
UPLC
Cell-based assays

Education

Bachelor’s degree in life science
Advanced degree preferred

Job description

Neurona Therapeutics in South San Francisco, CA seeks a QC Analyst III to support analytical testing for the clinical pipeline. The role reports to the Senior QC Manager and focuses on release, stability, and characterization assays, including flow cytometry, ddPCR, UPLC, and cell-based potency/viability tests.

The ideal candidate has 4–6 years in a cGMP QC lab, strong hands-on lab skills, and a track record of collaboration across QA, Assay Development, and Manufacturing to maintain regulatory

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