Position Summary
The QC Manager will lead quality control for the Pleasanton site, with responsibility for analytical, microbiology, environmental / support testing, and release readiness for cell culture media production. This role will establish fit-for-purpose QC systems, build the team, and ensure the site can support startup, routine operations, investigations, and continuous improvement.
Key Responsibilities
- Lead QC strategy and day-to-day execution across analytical, microbiology, assay, and environmental-support activities for media production.
- Build and manage QC workflows for raw material testing coordination, in-process support, finished goods release testing, stability support, and special studies as needed.
- Own QC laboratory readiness, including equipment, methods, scheduling, sample flow, reagents, reference materials, and documentation.
- Partner with QA, Production, Warehouse, and Technical teams on specifications, investigations, deviations, CAPAs, change controls, and lot disposition support.
- Establish a practical and scalable QC organization covering analytical and microbiology functions for startup and early operations.
- Ensure data integrity, good documentation practices, logbook control, and inspection readiness across the QC function.
- Support transfer, qualification, verification, and lifecycle management of QC methods relevant to media production and performance testing.
- Own QC SOPs, test forms, training plans, analyst qualification, and lab performance metrics.
- Manage contract labs and external testing partners where internal capability is not yet built out.
- Drive issue resolution with urgency while maintaining scientific soundness and quality expectations.
- Serve as a strong cross-functional leader who can help shape a pragmatic startup quality culture.
Qualifications
- Bachelor’s, Master’s, or PhD in chemistry, biochemistry, biology, microbiology, or a related scientific discipline.
- 8+ years of QC experience in biotech, media, or another regulated life sciences environment, with prior leadership experience.
- Strong understanding of analytical and microbiology lab operations, investigations, documentation, and quality systems.
- Experience supporting startup, scale-up, or new-site QC readiness is highly preferred.
- Able to build practical systems quickly without losing control of quality fundamentals.
Preferred Experience
- Experience with cell culture media, raw material variability, performance assays, and micro / sterility-related workflows.
- Hands-on familiarity with instruments such as HPLC/UPLC, Maurice or similar protein analysis tools, osmometer, and standard QC lab equipment.
- Experience managing both internal testing and external / contract testing strategies.
Working Conditions / Physical Requirements
- Able to work on-site in laboratory and controlled environments daily.
- Able to support occasional off-hours or weekend work tied to investigations, critical testing, or startup milestones.
Note
This job description is intended to describe the general scope of the role. Responsibilities may evolve as the Pleasanton site ramps and organizational needs change.
