Senior Director, CMC Team Leader

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.

oversee development from clinical to commercial phases, ensure regulatory compliance, and support product launch and lifecycle management.

• 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
• coordinate with manufacturing and supply chain for commercialization readiness

• 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

• experience supporting BLA/MAA submissions, commercialization, and late-stage clinical programs
• familiarity with autologous cell therapies

• biologics
• cell/gene therapies
• autologous products
• late-stage development
• regulatory strategy
• global filings
• process validation
• lifecycle management

• Process Development
• Analytical Development
• Quality
• Regulatory
• Supply Chain
• Program teams

Remote; no specific travel requirements stated.