Associate Director, Quality Control Technical Services
Beam Therapeutics
Cambridge, MA, United States
Base: $185,000 - $225,000 usd; bonus/equity: not s...
On-site
Ex vivo autologous cell therapy experience
Analytical method validation and transfer
Regulatory submission support for blas/inds
This role leads the Quality Control CMC strategy for Beam Therapeutics' ex vivo cell therapy franchise spanning late-stage development to commercial launch
Job Summary
This role leads the Quality Control CMC strategy for Beam Therapeutics' ex vivo cell therapy franchise spanning late-stage development to commercial launch.
The successful candidate will define and execute strategies for analytical method transfer, qualification, and validation across internal and external laboratories.
Key responsibilities include authoring CMC documentation for regulatory filings and serving as a technical subject matter expert for gene-edited cell therapy products.
Matching Summary
This role leads the Quality Control CMC strategy for Beam Therapeutics' ex vivo cell therapy franchise spanning late-stage development to commercial launch.
Salary
Base: $185,000 - $225,000 USD; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
ex vivo autologous cell therapy experience
analytical method validation and transfer
regulatory submission support for BLAs/INDs
mRNA drug substance testing expertise
cross-functional CMC team leadership
Nice-to-have
experience with automated analytical methods
strong statistical analysis collaboration skills
inspection-ready execution capabilities
internalization of external lab methods
Key Requirements
MS or PhD in Chemistry, Biochemistry, or related field
8+ years industry experience in QC or CMC
Direct experience with ex vivo autologous cell therapies
Proven track record supporting IND and BLA submissions