Role: Senior Director of Analytical Development within Centessa's CMC group, responsible for leading analytical strategies for small molecule drug substances and solid oral doses across development stages.
Responsibilities
Responsibilities include directing method development, validation, and transfer at external CDMOs, overseeing analytical data for regulatory filings, and ensuring compliance with cGMP and global regulatory standards. This role serves as a technical expert in characterization, stability, and impurity profile, supporting IND through registration activities, and collaborating with cross-functional teams including Quality and project management.
Qualifications
PhD in chemistry or pharmaceutical sciences (strongly preferred), 10+ years in small molecule pharma, extensive experience in early-phase analytical development, GMP validation, and managing outsourced analytical activities. Expertise in physical/chemical characterization, stability studies, and regulatory documentation is essential.
High-Value
Small molecule oral solid dose, early to late development stages, cGMP compliance, global regulatory support, leadership in analytical strategy, and external vendor management.
Work setup
US-based, full-time, with occasional international travel.
#J-18808-LjbffrSenior Director, Analytical Development CMC in boston at Unknown Company
This position is listed as full time and onsite.