CMC Quality Control Manager
US$93,000 – US$154,000 / yr base salary
Posted 15 Sep 2026
Advertised as “Manager/Senior Manager, CMC Quality Control”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 6+ yrs
- Management level
- Individual contributor
- Employment
- Hybrid
- Contract
- Full-time
| Base salary | US$93,000 – US$154,000 / yr |
|---|
Field of studyBiology, Biotechnology, Chemistry
Study levelBachelor's
Study levelMaster's
Role Summary
The Manager/Senior Manager, CMC Quality Control (QC) is responsible for providing strategic and operational oversight of QC activities supporting Lexeo's gene therapy programs. This role serves as a QC lead for external contract testing laboratories (CTLs), analytical lifecycle management (i.e., late-phase method validation), stability programs, release testing support, and analytical investigation activities.
The individual will work closely with Analytical Development, Technical Operations, Regulatory Affairs, Quality Assurance, and external partners to ensure analytical methods, specifications, and testing programs support clinical development, process validation readiness, and future commercial requirements.
This position requires technical expertise in analytical testing, preferably of AAV-based products, as well as demonstrated experience overseeing external laboratories and driving cross-functional CMC initiatives.
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