Associate Director, Formulation and Drug Product Development

Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.

Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities.

Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.

Strong experience and knowledge of cGMP manufacturing requirements.

Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability.

This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials.

Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing.

Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts.

Build and enhance internal capabilities for formulation development in the laboratory.

Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3).