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Director, Quality Control at Dyne Therapeutics - ApplyBlast

Director, Quality Control

Dyne Therapeutics

3 months ago

4.1 on Glassdoor

Waltham, MA

Onsite

Full Time

Director

0 applicants

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About this role

The Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and commercial stages. This role provides strategic direction and operational leadership to ensure compliant, efficient, and high-quality execution of QC activities from early development through BLA and commercialization while driving cross-functional alignment.

Responsibilities

Define and execute strategic vision for the Quality Control function
Oversee external QC laboratories and manage vendor performance
Review and approve analytical method qualification and validation protocols
Lead Out of Specification and Out of Trend investigations
Prepare analytical CMC content for regulatory submissions

Skills

Qualifications

Bachelor's degree in Biology, Biochemistry, Chemistry, or related disciplinePhD in Chemistry or Analytical Chemistry (strongly preferred)

About Dyne Therapeutics

dyne-tx.com

Headquarters

Waltham, Massachusetts, United States

Company Size

51-200 employees

Founded

2018

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Dyne Therapeutics is a biotechnology company developing nucleic acid–based therapies for genetically driven neuromuscular diseases. Leveraging its proprietary FORCE™ platform, Dyne aims to address the root cause of disease and deliver functional improvement for people living with conditions such as Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), and facioscapulohumeral muscular dystrophy (FSHD). The company advances a pipeline of therapeutics from discovery through clinical development with the mission of transforming the lives of patients with rare neuromuscular diseases.