Senior Director, Analytical Development

The Role: 

Generate:Biomedicines is seeking a Senior Director, Analytical Development to set the strategic direction and lead execution of analytical development for biologics programs in a lean, fully virtual development and manufacturing model. Reporting to the Vice President, Technical Operations, this leader will shape the future analytical operating model for Generate’s biologics portfolio, including analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external analytical operations, GMP readiness, and commercialization preparation across CDMO and contract testing partners.

This leader will manage and develop a small senior team that includes leaders for Analytical Development and external testing operations, while remaining deeply engaged in critical-path execution. In Generate’s lean model, this means rolling up their sleeves and providing hands-on leadership for high-impact technical decisions, partnering with the QA team to review batch-related analytical data and GMP documentation, support investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness.

The Senior Director will serve as the senior analytical partner to CMC, Process Development, MS&T, Quality, Regulatory, Supply Chain, and external partners, ensuring protein therapeutics are s