Senior Director, CMC Team Leader

Role: Senior Director, CMC Team Leader responsible for strategic leadership of Chemistry, Manufacturing, and Controls (CMC) activities for late-stage autologous cell therapy programs at Cabaletta Bio. Objectives: oversee development from clinical to commercial phases, ensure regulatory compliance, and support product launch and lifecycle management. Responsibilities: lead cross-functional CMC teams, develop integrated development and regulatory strategies, drive process development, validation, and comparability, manage regulatory submissions including INDs, BLAs, and MAAs, and coordinate with manufacturing and supply chain for commercialization readiness. Qualifications: PhD, MS, or equivalent in life sciences or engineering; 12+ years of biotech/pharma CMC experience, including biologics and cell/gene therapy; prior leadership in cross-functional program teams; deep knowledge of GMP, regulatory standards, and biologic development. Preferred: experience supporting BLA/MAA submissions, commercialization, and late-stage clinical programs; familiarity with autologous cell therapies. High-Value: biologics, cell/gene therapies, autologous products, late-stage development, regulatory strategy, global filings, process validation, lifecycle management. Collaboration: partner with Process Development, Analytical Development, Quality, Regulatory, Supply Chain, and Program teams. Work setup: Remote; no specific travel requirements stated.