QC Analyst III
Neurona Therapeutics
Summary
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. Maintaining active bench engagement, the QC Analyst III will 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. Additionally, this individual will 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.
Job description
Operational Coordination
- 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.
Analytical Testing & Data Analysis
- 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.
Quality Systems, Investigations & Method Lifecycle
- 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.
- 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.
Company overview
Neurona Therapeutics is a clinical-stage biotechnology company pioneering regenerative cell therapies for neurological disorders. The company specializes in developing allogeneic, off-the-shelf cell therapies derived from human pluripotent stem cells to treat chronic neurological conditions. Neurona's lead program focuses on NRTX-1001, an investigational cell therapy for drug-resistant focal epilepsy, which has shown promising results in early clinical trials. The company's proprietary platform enables the production of specific types of inhibitory interneurons that can restore neural circuit balance in the brain. Founded by leading neuroscientists, Neurona combines deep expertise in stem cell biology, neuroscience, and clinical development to address unmet medical needs in epilepsy, Alzheimer's disease, and other neurological disorders. The company's innovative approach represents a paradigm shift in treating chronic neurological conditions through regenerative medicine rather than symptom management alone.