QC Analyst III / Senior QC Analyst
About The Position
Neurona Therapeutics is seeking a highly motivated, detail-oriented candidate to join its Quality Control team in South San Francisco. The QC Analyst III / Senior QC Analyst supports analytical testing operations for the company’s clinical pipeline and reports directly to the Senior QC Manager. The role coordinates daily testing execution, manages shift priorities, and serves as the primary technical escalation point on the laboratory floor. The position maintains active bench engagement and independently performs complex release, stability, and characterization assays, with a focus on multiparameter flow cytometry, digital droplet PCR (ddPCR), UPLC, and cell-based potency and viability assays. The analyst also mentors junior personnel, conducts peer data review, authors technical quality records, and works closely with Assay Development and Quality Assurance to support analytical performance and cGMP compliance.
Requirements
- Bachelor’s degree in a life science discipline.
- 4–6 years of analytical laboratory experience in a cGMP biopharmaceutical, biotechnology, or cell/gene therapy QC environment.
- Working knowledge of cGMP regulations, ICH guidelines, and USP/EP standards.
- Experience authoring deviations, investigations, and SOPs.
- Strong communication, organization, and time-management skills.
Nice To Haves
- Advanced degree.
- Demonstrated proficiency in flow cytometry, ddPCR, UPLC, and cell-based assays.
Responsibilities
- Serve as a technical contact between Analytical QC, Manufacturing, and Quality Assurance during active testing windows.
- Lead timely performance of QC assays in the laboratory to support clinical manufacturing operations.
- Support QC Management in maintaining laboratory readiness, including 5S practices, reagent inventory, control materials, and analytical instrument validation, calibration, and preventive maintenance.
- Train and mentor QC personnel on analytical methods, instrumentation, and laboratory best practices.
- Perform cGMP testing for in-process samples, drug substance, drug product lot release, and stability protocols.
- Provide technical expertise, troubleshooting, and scientific support for flow cytometry, UPLC, ddPCR, and cell-based assays, escalating to QC Management as needed.
- Verify analytical testing reports, analytical data, test records, and associated GxP documentation for accuracy, completeness, and regulatory compliance.
- Participate in investigations of analytical deviations, laboratory events, and OOS/OOT results, including root cause analysis and CAPA implementation in partnership with QC and QA.
- Author and maintain SOPs, analytical methods, analyst qualification documents, protocols, and technical reports.
- Support analytical method transfers, qualifications, validations, and lifecycle management in collaboration with Assay Development and Process Sciences.
- Mentor junior analysts and perform peer data review.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
