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 with 8+ years or MS with 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