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About the Role
The QC Analyst III / Senior QC Analyst will support analytical testing operations for Neurona’s clinical pipeline, coordinating daily testing execution, managing shift priorities, and serving as the primary technical point of escalation for analytical assays. This role involves executing complex release, stability, and characterization assays, mentoring junior analysts, performing peer data review, authoring technical quality records, and ensuring cGMP compliance.
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 the QC Management in maintaining laboratory readiness through compliance with 5S practices, including reagent inventory, control materials, and analytical instrument (validation, calibration, PM).
- 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.
- Serve as a technical SME for Flow Cytometry, UPLC, ddPCR, and cell-based assays, providing troubleshooting and scientific support, or escalation to QC Management as needed.
- Verification of analytical testing reports, analytical data, test records, and associated GxP documentation to ensure accuracy, completeness, and compliance to regulatory standards.
- Participate in investigations of analytical deviations, laboratory events, and OOS/OOT results, including root cause analysis and CAPA implementation in partnership with QC 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.
Requirements
- Bachelor’s degree in a life science discipline; advanced degree preferred.
- 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.
Skills
- Multiparame ter flow cytometry
- Digital droplet PCR (ddPCR)
- UPLC
- Cell-based potency/viability assays
- Flow Cytometry
- ddPCR
- UPLC
- Cell-based assays
Location
- South San Francisco, CA
Work Type
- On-site
Experience Level
- 4-6 years
Education Level
- Bachelor's degree in a life science discipline
- Advanced degree preferred
Salary/Compensations
- $107,000 - $130,000
About the Company
- Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on developing neuronal cell-based therapies for intractable neurological diseases.
Equal Opportunity
- Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.