Manager/Senior Manager, CMC Quality Control

Primary Responsibilities

- Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing activities

- Support product specification lifecycle management, including establishment, justification, trending, revision, and regulatory impact assessment

- Partner with Analytical Development and Technical Operations to support method qualification, validation, transfer, verification, and continued performance monitoring across testing laboratories

- Serve as QC subject matter expert for laboratory investigations, including OOS, OOT, atypical results, assay failures, and method performance events

- Support reference standard qualification, lifecycle management, and analytical comparability initiatives

- Provide technical oversight for method transfers, comparability assessments, and laboratory readiness

- Collaborate with Regulatory Affairs and CMC teams to author and review regulatory submissions, responses to health authority inquiries, technical reports, and analytical sections of INDs, BLAs, and other global filings

- Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents

- Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements

- Collaborate with cross-functional CMC teams to align on sample submission and testing needs

Required Skills and Qualifications

- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology); advanced degree (MS) a plus

- 6+ years of experience or 4+ with Master’s (Sr. Manager level: BS + 8 years or MS + 6 years experience) in Quality Control, Analytical Development, Manufacturing Sciences, Quality Assurance, or related CMC functions within biotechnology or pharmaceutical organizations

- Experience supporting late-stage development, process validation, and/or commercial readiness activities preferred

- Experience supporting biologics, cell therapy, gene therapy, or other advanced therapeutics preferred

- Strong understanding of cGMP regulations and global regulatory expectations applicable to analytical testing and Quality Control

- Experience with analytical method lifecycle management, including qualification, validation, transfer, verification, and continued performance monitoring

- Knowledge of analytical techniques commonly used for AAV and biologic products (i.e., ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, compendial safety testing)

- Strong understanding of analytical control strategy development and specification management

Compensation is dependent on qualifications and experience