Associate Director, Drug Product Manufacturing
Dyne Therapeutics•Waltham, MA
•Onsite
About The Position
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.
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
Nice To Haves
- advanced degree preferred
Responsibilities
- 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
- 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
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
