Associate Director, Drug Product Manufacturing
Role Summary
The Associate Director, Drug Product Manufacturing is accountable for leading drug product manufacturing activities to support the development and commercialization of Dyne’s therapies. This role ensures successful execution of clinical and commercial manufacturing operations for parenteral drug products and partners cross-functionally to deliver uninterrupted clinical supply. The role provides technical leadership across CDMOs and contributes to scalable, compliant manufacturing processes aligned with Dyne’s FORCE™ platform.
Primary Responsibilities Include
Lead clinical and commercial drug product manufacturing activities for large molecule, sterile injectable programs (liquid and lyophilized)
Serve as the primary technical owner for drug product manufacturing at CDMOs, providing strategic direction and hands-on oversight across clinical campaigns from pre-IND through commercial
Drive day-to-day manufacturing activities, including preparation and review of batch records and process documentation
Maintain on-site presence at CDMOs during manufacturing campaigns to ensure execution quality and provide real-time technical guidance
Oversee batch disposition activities in collaboration with Quality Assurance
Manufacturing Operations & Continuous Improvement
Lead investigation and resolution of manufacturing deviations, process failures, and yield issues
Author and review deviation reports, investigations, CAPAs, and change controls
Identify and implement process improvements through change control and validation activities
Evaluate new manufacturing technologies with a focus on scalability and robustness
Tech Transfer & Development Support
Drive tech transfer activities for internal and external manufacturing partners, including development of plans, instructions, and risk assessments
Partner with internal and external teams on process development and characterization to support regulatory submissions (IND/IMPD, BLA/MAA)
Ensure manufacturing processes are aligned with clinical and commercial needs
Cross-Functional Collaboration & Compliance
Represent drug product manufacturing on cross-functional teams, communicating program status, risks, and mitigation strategies
Partner closely with QA to ensure all GMP activities align with internal quality systems and regulatory expectations
Collaborate with supply chain to ensure clinical supply continuity and planning execution
Author and review technical reports and regulatory submission sections related to drug product
Education and Skills Requirements
Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline; advanced degree preferred
8+ years (BS) or 3+ years (MS) of relevant drug product manufacturing experience
Experience in parenteral drug product manufacturing with CDMO oversight
Strong knowledge of sterile manufacturing and fill-finish operations
Experience with batch records, deviations, and tech transfer
Deep understanding of cGMP and regulatory expectations (FDA, EMA)
Strong troubleshooting and problem-solving capabilities
Effective cross-functional collaboration skills
Strong written and verbal communication skills
Ability to manage multiple programs in a fast-paced environment
MA Pay Range
$160,000 - $196,000 USD
Company
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
CONNECT
Stock Symbol: DYN
Stock Exchange: Nasdaq
Website
https://www.dyne-tx.com/