Manager, GMP Quality Control

Job Description

Job Description

Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities. Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027.

CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.

We are seeking qualified individuals to join us as Quality Control Manager. Core duties and responsibilities include the following:

Job Duties:

• Lead and develop a QC laboratory team of approximately 5–8 analysts and chemists; manage daily priorities, workload, scheduling, training, qualification, performance, and backup coverage.
• Maintain a regular hands-on presence in the laboratory to understand process details, coach analysts, answer technical questions, and help troubleshoot testing and instrument issues in real time.
• Ensure timely execution and documentation of in-process, raw-material, release, stability, cleaning, investigation, or other assigned testing in accordance with approved methods, specifications, SOPs, and schedules.
• Review analytical data, calculations, chromatograms, audit trails, worksheets, and reports for accuracy, completeness, data integrity, and compliance.
• Oversee and contribute to analytical method transfer, verification, validation, troubleshooting, and lifecycle improvement for peptide characterization methods, including HPLC and LC-MS-based methods as applicable.
• Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, and change controls; ensure actions are scientifically sound, documented, and completed on time.
• Coordinate instrument qualification, calibration, preventive maintenance, service, troubleshooting, and laboratory supply readiness for assigned equipment.
• Partner with Quality Assurance on specifications, testing status, investigations, and batch-disposition decisions; provide complete QC data and recommendations while preserving QA’s final disposition authority.
• Support process characterization, scale-up, technology transfer, new-product introduction, and customer method transfer by providing practical analytical planning and execution.
• Prepare or review QC portions of regulatory, customer, and technical data packages; ensure source data and controlled records are complete and traceable.
• Serve as the QC subject-matter expert during regulatory, customer, and internal audits and support responses and corrective actions for QC-related observations.
• Manage laboratory vendors, service providers, operating supplies, and the approved QC budget.
• Track and communicate laboratory metrics including turnaround time, schedule adherence, right-first-time documentation, investigation aging, instrument availability, and training status.
• This is not a desk-only scheduling role. The Manager is expected to understand the work at the process and instrument level and remain available on the laboratory floor when the team needs technical direction.
• The Manager must be able to demonstrate procedures, train personnel, review work, troubleshoot issues, and make sound decisions about when testing may proceed, pause, or require escalation.
• The role requires balancing laboratory presence with planning, documentation review, people management, meetings, and cross-functional coordination.

Requirements

• Bachelor’s degree in chemistry, analytical chemistry, pharmaceutical sciences, biochemistry, or a related discipline.
• 6+ years of analytical chemistry or QC experience in pharmaceutical, biopharmaceutical, API, or another GMP-regulated environment.
• 5+ years of hands-on experience with HPLC, LC-MS, or other relevant analytical instrumentation and data systems.
• 2+ years of direct leadership experience supervising a QC laboratory, analytical team, or comparable technical group.
• Working expertise in analytical method validation or verification, release testing, stability testing, and cGMP laboratory documentation.
• Strong understanding of data integrity, OOS/OOT investigations, deviations, CAPA, change control, instrument qualification, and controlled methods.
• Demonstrated ability to train analysts, troubleshoot technical problems, set priorities, and maintain testing turnaround in a fast-moving environment.
• Strong written and verbal communication and the ability to work effectively across Manufacturing, Quality Assurance, Materials, Validation, and Project Management.

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities