Lead, Formulation & Drug Product Development

BioSpace; Waltham (MA); On-site; USD 159,000 - 195,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA, is seeking an Associate Director of Formulation and Drug Product Development to lead internal and external formulation efforts. You will drive drug product development, support tech transfer and scale-up, and ensure supply for clinical trials across Phases 1–3.

The role requires a PhD or equivalent, 8+ years in clinical drug product formulation, and strong collaboration across Regulatory Affairs, Quality, and Manufacturing.

Qualifications

• PhD or equivalent in a scientific discipline with 8+ years of experience.
• Experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations and other injectables.
• Strong knowledge of cGMP manufacturing requirements and external manufacturing operations.
• Excellent interpersonal and cross-functional communication skills with ability to lead and influence.
• Strategic thinker with urgency to deliver quality results on time in a fast-paced biotech environment.

Responsibilities

• Act as SME for drug product development within Technical Development, including formulation development and sterile fill finish.
• Liaise with CDMO(s) for external formulation development and with Research to define early-stage efforts.
• Build and enhance internal capabilities for formulation development in the laboratory.
• Oversee development, tech transfer, and scale-up of drug product processes and cGMP manufacturing for clinical grades (Phases 1–3).
• Contribute to drug product sections of early-stage filings (INDs/IMPDs).
• Collaborate across Technical Development, Manufacturing, Quality Control, QA and Regulatory Affairs to ensure continuity of drug supply.
• Drive execution of formulation development plans at CDMO and maintain project cadence.
• Foster a winning culture and teamwork through transparent communication and collaboration.

Skills

Strategic thinking

Collaboration

Communication

Project management

Education

PhD or equivalent

Tools

External manufacturing

Job description

Dyne Therapeutics in Waltham, MA, is seeking an Associate Director of Formulation and Drug Product Development to lead internal and external formulation efforts. You will drive drug product development, support tech transfer and scale-up, and ensure supply for clinical trials across Phases 1–3.

The role requires a PhD or equivalent, 8+ years in clinical drug product formulation, and strong collaboration across Regulatory Affairs, Quality, and Manufacturing.