Associate Director, Formulation and Drug Product Development

Role: Associate Director of Formulation and Drug Product Development, responsible for advancing formulation strategies for Dyne's bioconjugate therapeutics targeting neuromuscular and CNS diseases. Core responsibilities include leading formulation development, selecting container systems, liaising with CDMOs, and managing tech transfer and scale-up for Phase 1-3 clinical manufacturing. The role also involves contributing to early clinical filings and ensuring continuous clinical supply through cross-functional collaboration with Research, Quality, Manufacturing, and Regulatory teams. Qualifications: PhD or equivalent with 8+ years in drug product formulation, with proven expertise in liquid fill finish, lyophilization, subcutaneous formulations, and sterile manufacturing. Deep knowledge of cGMP standards and external manufacturing processes required. Preferred skills include strategic planning, cross-functional influence, and experience with early-stage clinical development and regulatory submissions (INDs/IMPDs). High-value specifics: focus on biologics/bioconjugates for neuromuscular and CNS indications, with emphasis on formulations suitable for clinical trials. Work setup: onsite in Waltham, MA (4-5 days/week), with no remote option.