Dyne Therapeutics
Associate Director, Formulation and Drug Product Development
Waltham, MA · Director
Sponsorship not specified$159k-$195kDetected 21 days ago
GMPFDA RegulatoryResearchAnimal StudiesCommunicationRegulatory Affairs
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
- Build and enhance internal capabilities for formulation development in the laboratory.
- Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation.
Requirements
- PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
- Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Strong experience and knowledge of cGMP manufacturing requirements.
- Experience managing complex schedules and priorities in a dynamic biotech environment.
- Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs).
- Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships.
Compensation
- $159,000 - $195,000 USD
Benefits
- Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
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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