Associate Director, Formulation and Drug Product Development

Responsibilities

• Act as the subject matter expert for drug product development, including formulation development, container closure systems, and sterile fill finish clinical manufacturing
• Serve as the main point of contact for CDMOs for external formulation development activities
• Build and enhance internal laboratory capabilities for formulation development
• Manage development, tech transfer, scale-up, and cGMP manufacturing of clinical grade drug products (Phase 1-3)
• Contribute to drug product sections of early-stage clinical filings such as INDs, IMPDs, and Health Canada filings
• Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure drug supply continuity
• Drive execution of formulation development plans at CDMOs from PO through delivery

Requirements

• PhD or equivalent experience in a scientific discipline
• Minimum of 8+ years of related experience
• Proven experience in clinical drug product formulation development (liquid fill finish, lyophilization, subcutaneous formulations, and injectables)
• Expertise in sterile fill-finish early clinical manufacturing and supporting analytical techniques
• Understanding of external manufacturing operations from development to clinical manufacturing
• Strong knowledge of cGMP manufacturing requirements
• Experience managing complex schedules in a dynamic biotech environment
• Strong cross-functional collaboration and communication skills

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.