QC Lead / ManagerLocation: South San Francisco, CA, 94080
Role OverviewThe QC Lead / Manager will report directly to the Director, Assay Development & QC and provide operational and technical leadership for the Quality Control laboratory activities supporting Neurona's cell therapy programs. As an in-lab leader for Quality Control, this role will be responsible for scheduling all QC testing for lot release, stability plans and ad hoc test requests, in addition to managing test samples and reagent inventories, in accordance with cGMP and regulatory standards.
This role will also serve as a key liaison between QC, Manufacturing, and Quality Assurance teams to ensure product quality and operational excellence. In addition to leadership responsibilities, this individual will remain actively engaged at the bench, serving as a subject matter expert for Quality events and reviewing data to support critical QC deliverables.
ResponsibilitiesOperational Leadership- Coordinate scheduling and execution of QC assays for lot release, stability programs and ad hoc testing, ensuring timelines and quality standards are met.
- Manage laboratory operations, including sample tracking, inventory control, and equipment readiness.
- Review and approve data to ensure accuracy, completeness, and compliance.
- Active involvement, including training and running QC tests, to support laboratory assay performance while maintaining testing throughput and timelines.
Compliance & Inspection Readiness- Ensure adherence to cGMP, GxP, and pharmacopeia standards across all QC activities.
- Lead inspection readiness efforts and support internal and external audits.
- Oversee and manage deviations, OOS/OOT investigations, and CAPAs, ensuring timely resolution and documentation.
- Champion data integrity and documentation best practices within the QC laboratory.
Method Lifecycle Management- Oversee method transfer, qualification, validation, and lifecycle management within the QC lab.
- Support assay optimization and troubleshooting to ensure robustness and reproducibility.
- Partner with Assay Development and Process Sciences teams to implement new or improved methods.
Strategic Collaboration- Serve as a key liaison between QC and cross-functional stakeholders, including Manufacturing, CMC, and Site QA.
- Support batch release activities and ensure alignment between QC deliverables and manufacturing timelines.
- Collaborate with Quality and technical teams to resolve complex quality and process-related issues.
Continuous Improvement- Drive process improvements in laboratory workflows, efficiency, and throughput.
- Identify and implement new technologies and automation to enhance QC capabilities.
- Track and report key performance metrics to support operational excellence initiatives.
Education Requirements- Bachelor's degree in Biochemistry, Microbiology, Chemistry, or related scientific discipline (Master's degree a plus)
Experience Requirements- 5+ years of experience in a pharmaceutical or biotechnology QC laboratory environment.
- Prior experience leading or mentoring teams in a QC or laboratory setting.
- Demonstrated hands-on laboratory experience with a willingness to remain actively engaged in day-to-day operations.
- Strong knowledge of cGMP regulations, pharmacopeia standards, and Quality Systems.
- Demonstrated experience managing deviations, OOS investigations, and CAPAs.
- Proven ability to lead method transfer, validation, and lifecycle management activities.
- Strong technical writing and documentation skills.
- Excellent organizational, communication, and cross-functional collaboration skills.
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