Associate Director, Drug Product Manufacturing
$160,000–$196,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead clinical and commercial drug product manufacturing activities for large molecule, sterile injectable programs, serving as the primary technical owner at CDMOs from pre-IND through commercial phases. Drive day-to-day manufacturing execution, including preparation and review of batch records, while maintaining on-site presence to ensure quality and provide real-time technical guidance. Oversee batch disposition activities, lead investigations of deviations and process failures, and implement process improvements through change control and validation. Partner cross-functionally with QA and supply chain to ensure uninterrupted clinical supply and regulatory alignment for Dyne's therapies targeting neuromuscular diseases.
Required Qualifications
- Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
- 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
Desired Qualifications
- Advanced degree
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