Dyne Therapeutics
Director, Biologics Development
Waltham, MA · Director
Sponsorship not specified$190k-$230kDetected 8 days ago
Project ManagementGMPFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationProblem SolvingPublic Speaking
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.
Responsibilities
- Lead the design, optimization, and execution of process development for biologics, ensuring scalability for clinical and commercial supply.
Requirements
- 10+ years of biopharmaceutical industry experience with demonstrated progression in biologics development
- Experience leading teams or cross-functional initiatives in a matrixed environment
- Proven track record advancing biologics programs from early development through clinical cGMP manufacturing
- Deep expertise in protein expression, purification, and biologics process development
- Experience defining and executing CMC strategies from pre-IND through clinical development
- Strong track record managing CDMOs, including oversight and technology transfer
- Working knowledge of FDA, EMA, and ICH guidelines, with experience contributing to Module 3 regulatory filings
- Experience in analytical development, including impurity control, viral safety, and physicochemical characterization
- Excellent communication skills, with the ability to clearly convey complex technical concepts
Nice to have
- Bachelor's degree in Biology, Biochemistry, Pharmaceutical Sciences, or related discipline
- advanced degree preferred
Skills
- Define Dyne's strategy for implementation of new technologies to lower cost-of-goods
Compensation
- $190,000 - $230,000 USD
Company info
- 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.
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