Dyne Therapeutics

Associate Director, Drug Product Manufacturing

Waltham, MA · Director

Sponsorship not specified$160k-$196kDetected 15 days ago

Supply ChainGMPFDA RegulatoryAnimal StudiesLeadershipCommunicationCollaborationProblem Solving

About the role

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

8+ years (BS) or 3+ years (MS) of relevant drug product manufacturing experience
Experience in parenteral drug product manufacturing with CDMO oversight
Strong knowledge of sterile manufacturing and fill-finish operations
Experience with batch records, deviations, and tech transfer

Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
advanced degree preferred

Oversee batch disposition activities in collaboration with Quality Assurance
Author and review deviation reports, investigations, CAPAs, and change controls
Evaluate new manufacturing technologies with a focus on scalability and robustness
Ensure manufacturing processes are aligned with clinical and commercial needs
Represent drug product manufacturing on cross-functional teams, communicating program status, risks, and mitigation strategies
Author and review technical reports and regulatory submission sections related to drug product

We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.