Dyne Therapeutics
Senior Director, Quality Control
Waltham, MA · Director
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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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Requirements
- Bachelor's degree in biology, analytical chemistry, biochemistry, or a related field.
- 15+ years of experience in Analytical Development and Quality Control, or equivalent experience, including significant leadership of people or a function.
- Strong GMP Quality Control background, including experience with compendial and product-specific assays for antibodies and small molecules.
- Strong knowledge of current Good Manufacturing Practices and applicable International Council for Harmonisation, U.S. Food and Drug Administration, and European Union regulations.
- Experience establishing and maintaining drug substance and drug product specifications, stability programs, reference standard programs, and laboratory compliance systems.
- Strong understanding of data integrity requirements, change controls, corrective and preventive actions, and out-of-specification and out-of-trend investigations.
- Ability to operate effectively in a highly matrixed, fast-paced, and evolving environment.
- Sound judgment and the ability to make decisions involving complex technical, compliance, operational, and organizational considerations.
Nice to have
- Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred.
Skills
- Define and execute the Quality Control strategy in alignment with quality and business objectives.
- Represent Quality Control during regulatory inspections.
- Oversee external testing laboratory operations, release and stability testing, and the issuance of Certificates of Analysis.
- Review environmental monitoring, sterility, bioburden, and endotoxin data and participate in related reviews and investigations.
- Oversee the reference standard program across external testing vendors.
- Establish clear priorities, promote accountability, and ensure resources are aligned with functional and organizational objectives.
Compensation
- $240,000 - $285,000 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.
This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.