Associate Director, Formulation and Drug Product Development
Dyne Therapeutics
August 30, 2026
On-site
Waltham, MA
Operations
Role Summary
- Accountable for all internal and external activities related to successful formulation development for bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability.
- Partners with Research, Pharmaceutical Quality, and Manufacturing to define strategy for best-in-class medicines, including high-concentration subcutaneous formulations and lyophilized drug products for seamless clinical trial supply.
- Onsite role in Waltham, MA (4–5 days/week); not remote.
Primary Responsibilities
- Subject matter expert for drug product development (formulation development, container closure system selection, sterile fill-finish clinical manufacturing).
- Main point of contact for CDMO(s) for external formulation development; liaise with Research for early-stage formulation execution.
- Build and enhance internal formulation development capabilities.
- Develop, tech transfer, and scale up drug product processes; lead cGMP manufacturing of clinical grade drug product (Phase 1–3).
- Contribute to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
- Collaborate across Technical Development, Manufacturing, QC, QA, and Regulatory Affairs to ensure drug supply continuity.
- Drive formulation development plan execution at CDMO (PO through delivery).
- Champion a winning culture through transparent communication and collaboration.
Education & Skills Requirements
- PhD (or equivalent) and 8+ years related experience.
- Clinical drug product formulation experience: liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Sterile fill-finish early clinical manufacturing expertise; knowledge of analytical techniques supporting manufacturing.
- Understanding of external manufacturing operations from development to clinical manufacturing.
- Strong cGMP manufacturing knowledge.
- Strategic, urgent, ethical, and professional; manages complex schedules/priorities.
- Ability to influence and gain consensus across Technical Operations, Quality, and Regulatory Affairs.
- Excellent interpersonal, verbal, and written communication; resilient in fast-paced, multi-program/vendor environments.
- Accountable for all internal and external activities related to successful formulation development for bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability.
- Partners with Research, Pharmaceutical Quality, and Manufacturing to define strategy for best-in-class medicines, including high-concentration subcutaneous formulations and lyophilized drug products for seamless clinical trial supply.
- Onsite role in Waltham, MA (4–5 days/week); not remote.
Primary Responsibilities
- Subject matter expert for drug product development (formulation development, container closure system selection, sterile fill-finish clinical manufacturing).
- Main point of contact for CDMO(s) for external formulation development; liaise with Research for early-stage formulation execution.
- Build and enhance internal formulation development capabilities.
- Develop, tech transfer, and scale up drug product processes; lead cGMP manufacturing of clinical grade drug product (Phase 1–3).
- Contribute to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
- Collaborate across Technical Development, Manufacturing, QC, QA, and Regulatory Affairs to ensure drug supply continuity.
- Drive formulation development plan execution at CDMO (PO through delivery).
- Champion a winning culture through transparent communication and collaboration.
Education & Skills Requirements
- PhD (or equivalent) and 8+ years related experience.
- Clinical drug product formulation experience: liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Sterile fill-finish early clinical manufacturing expertise; knowledge of analytical techniques supporting manufacturing.
- Understanding of external manufacturing operations from development to clinical manufacturing.
- Strong cGMP manufacturing knowledge.
- Strategic, urgent, ethical, and professional; manages complex schedules/priorities.
- Ability to influence and gain consensus across Technical Operations, Quality, and Regulatory Affairs.
- Excellent interpersonal, verbal, and written communication; resilient in fast-paced, multi-program/vendor environments.