Associate Director, Formulation and Drug Product Development
Dyne Therapeutics
June 27, 2026
On-site
Waltham, MA
Operations
Associate Director, Formulation and Drug Product Development
Responsibilities:
- Serve as subject matter expert for drug product development (formulation development, container closure system selection, and sterile fill-finish clinical manufacturing).
- Primary point of contact for CDMO(s) for external formulation development; partner with Research to define, streamline, and execute early-stage formulation development.
- Build and enhance internal formulation development capabilities in the laboratory.
- Lead development, tech transfer, and scale-up of drug product processes; oversee 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 with Technical Development, Manufacturing, QC, QA, and Regulatory Affairs to maintain continuity of drug supply for early clinical evaluation.
- Drive CDMO execution of the formulation development plan (PO through delivery).
Qualifications/Requirements:
- PhD (or equivalent) in a scientific discipline and 8+ years of related experience.
- Proven clinical drug product formulation experience: liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Expertise in sterile fill-finish early clinical manufacturing and analytical techniques supporting manufacturing.
- Understanding of external manufacturing operations from development through clinical manufacturing.
- Strong knowledge of cGMP manufacturing requirements.
- Ability to manage complex schedules/priorities; work/influence across Technical Operations, Quality, and Regulatory Affairs; collaborative problem-solving.
Location: Waltham, MA; onsite 4–5 days/week (no remote option).
Pay Range: $159,000–$195,000 USD.
Responsibilities:
- Serve as subject matter expert for drug product development (formulation development, container closure system selection, and sterile fill-finish clinical manufacturing).
- Primary point of contact for CDMO(s) for external formulation development; partner with Research to define, streamline, and execute early-stage formulation development.
- Build and enhance internal formulation development capabilities in the laboratory.
- Lead development, tech transfer, and scale-up of drug product processes; oversee 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 with Technical Development, Manufacturing, QC, QA, and Regulatory Affairs to maintain continuity of drug supply for early clinical evaluation.
- Drive CDMO execution of the formulation development plan (PO through delivery).
Qualifications/Requirements:
- PhD (or equivalent) in a scientific discipline and 8+ years of related experience.
- Proven clinical drug product formulation experience: liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Expertise in sterile fill-finish early clinical manufacturing and analytical techniques supporting manufacturing.
- Understanding of external manufacturing operations from development through clinical manufacturing.
- Strong knowledge of cGMP manufacturing requirements.
- Ability to manage complex schedules/priorities; work/influence across Technical Operations, Quality, and Regulatory Affairs; collaborative problem-solving.
Location: Waltham, MA; onsite 4–5 days/week (no remote option).
Pay Range: $159,000–$195,000 USD.