Associate Director, Formulation and Drug Product Development
Dyne Therapeutics
August 09, 2026
On-site
Waltham, MA
Operations
Role Summary
Associate Director, Formulation and Drug Product Development. Accountable for internal and external activities for successful formulation development of Dyne’s bioconjugate drug products to ensure manufacturability, product quality, and long-term stability. Partners with Research, Pharmaceutical Quality, and Manufacturing; includes high-concentration subcutaneous formulations and lyophilized products for clinical trials.
Primary Responsibilities
- Act as subject matter expert for drug product development: formulation development, container closure system selection, and sterile fill-finish clinical manufacturing.
- Main point of contact for CDMO(s) for external formulation development; liaise with Research to define/streamline/execute early-stage formulation development.
- Build and enhance internal laboratory capabilities for formulation development.
- 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 filings (INDs/IMPDs/Health Canada).
- Collaborate with Technical Development, Manufacturing, QC, QA, and Regulatory Affairs to ensure continuity of drug supply.
- Drive CDMO execution of the formulation development plan (PO through delivery).
- Champion a winning culture through transparent communication and collaboration.
Qualifications / Requirements
- PhD (or equivalent) and 8+ years related experience.
- Clinical drug product formulation experience: liquid fill finish, lyophilization, subcutaneous formulations, other injectables.
- Sterile fill-finish early clinical manufacturing expertise; understanding of analytical techniques supporting manufacturing.
- Understanding of external manufacturing operations from development to clinical manufacturing.
- Strong cGMP manufacturing knowledge.
- Strategic, urgent, ethical, professional; manages complex schedules/priorities.
- Ability to influence/gain consensus across functions; collaborative, gap-identifying problem solver.
- Excellent interpersonal, verbal, and written communication; resilient in fast-paced environments.
Onsite Requirement
- Based in Waltham, MA; not remote. Onsite 4–5 days/week.
Pay Range
- $159,000 - $195,000 USD.
Associate Director, Formulation and Drug Product Development. Accountable for internal and external activities for successful formulation development of Dyne’s bioconjugate drug products to ensure manufacturability, product quality, and long-term stability. Partners with Research, Pharmaceutical Quality, and Manufacturing; includes high-concentration subcutaneous formulations and lyophilized products for clinical trials.
Primary Responsibilities
- Act as subject matter expert for drug product development: formulation development, container closure system selection, and sterile fill-finish clinical manufacturing.
- Main point of contact for CDMO(s) for external formulation development; liaise with Research to define/streamline/execute early-stage formulation development.
- Build and enhance internal laboratory capabilities for formulation development.
- 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 filings (INDs/IMPDs/Health Canada).
- Collaborate with Technical Development, Manufacturing, QC, QA, and Regulatory Affairs to ensure continuity of drug supply.
- Drive CDMO execution of the formulation development plan (PO through delivery).
- Champion a winning culture through transparent communication and collaboration.
Qualifications / Requirements
- PhD (or equivalent) and 8+ years related experience.
- Clinical drug product formulation experience: liquid fill finish, lyophilization, subcutaneous formulations, other injectables.
- Sterile fill-finish early clinical manufacturing expertise; understanding of analytical techniques supporting manufacturing.
- Understanding of external manufacturing operations from development to clinical manufacturing.
- Strong cGMP manufacturing knowledge.
- Strategic, urgent, ethical, professional; manages complex schedules/priorities.
- Ability to influence/gain consensus across functions; collaborative, gap-identifying problem solver.
- Excellent interpersonal, verbal, and written communication; resilient in fast-paced environments.
Onsite Requirement
- Based in Waltham, MA; not remote. Onsite 4–5 days/week.
Pay Range
- $159,000 - $195,000 USD.