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Senior Director, Quality Control

Dyne Therapeutics · Waltham, MA · On-site

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About Dyne Therapeutics

Backed by Atlas Venture.

About the role

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. 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.

What they're looking for

  • Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field
  • Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred
  • 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
  • Demonstrated experience overseeing contract testing laboratories, analytical method lifecycle activities, release and stability programs, and inspection readiness
More about this role

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. 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. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing, pipeline advancement, and product lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical support across external testing laboratories, including release and stability testing.

The Senior Director partners closely with contract manufacturing and testing organizations and collaborates across Analytical...

Read the full posting on Dyne Therapeutics's site ↗

GL - Quality

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