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About the Role
The QC Analyst III will report directly to the Senior QC Manager and support analytical testing operations for Neurona’s clinical pipeline. This role coordinates daily testing execution, manages shift priorities, and serves as the primary technical point of escalation on the floor for analytical 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 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.
- Independently execute complex release, stability, and characterization assays—specifically focusing on multiparameter flow cytometry, digital droplet PCR (ddPCR), UPLC, and cell-based potency/viability assays.
- Mentor junior analysts, perform peer data review, author technical quality records, and partner closely with Assay Development and QA to ensure robust analytical performance and strict cGMP compliance.
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.
- Strong preference for candidate with demonstrated proficiency in 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.
- Strong communication, organization, and time-management skills.
Skills
- Flow Cytometry
- ddPCR
- UPLC
- Cell-based assays
- cGMP regulations
- ICH guidelines
- USP/EP standards
- Deviation authoring
- Investigation authoring
- SOP authoring
- Communication
- Organization
- Time-management
Location
- South San Francisco
Work Type
- Onsite
Experience Level
- 4-6 years
Education Level
- Bachelor's degree
- Advanced degree preferred
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.