Role Summary:

The Drug Product Manufacturing role will be accountable for all activities related to successful development and manufacturing operations and drug product related activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless supply of all drug products for clinical trials.

This on-site role is based in Waltham, MA without the possibility of being fully remote.

Senior Manager, Drug Product Manufacturing

Lead clinical and commercial drug product manufacturing activities for large molecule, parenteral programs (liquid and lyophilized sterile injectables) to support the Dyne FORCE platform, including:

• Serve as primary technical owner for drug product manufacturing at CDMOs, providing hands-on oversight and strategic direction across clinical manufacturing campaigns from pre-IND through commercial
• Drive day-to-day manufacturing activities, including preparation and review of batch records and process documentation to ensure successful clinical supply delivery
• Lead troubleshooting of manufacturing deviations, process failures, and yield issues; author and review deviation reports, investigations, CAPAs, and change controls
• Maintain on-site presence at CDMOs during batch manufacturing to provide real-time technical guidance and ensure execution integrity
• Oversee clinical supply planning and batch disposition activities in collaboration with supply chain and QA partners

Support activities to ensure supply chain robustness and clinical readiness:

• Drive tech transfer activities for current and new products, such as preparation of tech transfer plans, manufacturing instructions, and risk assessments
• Enact manufacturing process improvements through change control and process validation activities
• Partner with internal and external labs on process development and characterization activities to support IND/IMPD and BLA/MAA submissions
• Evaluate new technology options with a focus on manufacturability and scalability

Represent drug product manufacturing in cross-functional teams, effectively communicating program status, manufacturing risks, and mitigation strategies. Work closely with QA to ensure all GMP activities align with internal QMS requirements. Author and review technical reports and drug product sections of regulatory filings.

Education and Skills Requirements:

• Degree in Chemistry, Chemical Engineering, Pharmaceutical Science, or equivalent with commensurate experience (BS + 8 years of experience, or MS + 3 years of experience)
• Experience in parenteral drug product clinical manufacturing, with direct CDMO oversight experience across multiple clinical phases
• Strong working knowledge of sterile manufacturing processes, equipment, and fill-finish unit operations
• Experience managing drug product manufacturing activities at external CDMOs, including batch record review, deviation management, and tech transfer
• Deep knowledge of cGMP, FDA/EMA regulatory expectations, and current quality guidelines
• Demonstrated ability to troubleshoot complex manufacturing challenges in fast-paced, multi-program environments
• Strong communicator with the ability to drive alignment across QA, CMC, regulatory, and supply chain functions
• Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise- wide, from the executive team to the manufacturing floor.
• Resilient, able to work in a demanding, fast-paced environment, and capable of supporting multiple programs and vendors.

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