Senior Manager, Drug Product Manufacturing (Parenteral/CDMO)

Dyne Therapeutics; Waltham (MA); On-site; USD 150,000 - 185,000; Full time

Job summary

Dyne Therapeutics is seeking a Senior Manager, Drug Product Manufacturing, to lead clinical and commercial drug product manufacturing for large molecule parenteral programs at CDMOs. This onsite role in Waltham, MA will drive batch records, deviations, tech transfer, and supply planning across IND/IMPD and BLA/MAA submissions.

The candidate will oversee manufacturing campaigns from pre-IND through commercial with strong cGMP knowledge and proven cross-functional leadership across QA, regulatory,

Qualifications

• BS in Chemistry, Chemical Engineering, Pharmaceutical Science, or equivalent with commensurate experience (BS + 8 years, or MS + 3 years)
• Experience in parenteral drug product clinical manufacturing with CDMO oversight across multiple clinical phases
• Strong knowledge of sterile manufacturing processes, equipment, and fill-finish 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
• Ability to troubleshoot complex manufacturing challenges in fast-paced, multi-program environments
• Strong communication across QA, CMC, regulatory, and supply chain
• Excellent interpersonal, verbal, and written communication, with cross-functional collaboration

Responsibilities

• Serve as primary technical owner for drug product manufacturing at CDMOs with oversight and direction across campaigns from pre-IND through commercial
• Drive day-to-day manufacturing activities and prepare/review batch records and process docs for clinical supply
• Lead troubleshooting of deviations, process failures, and yield issues; author/review deviation reports, investigations, CAPAs, and change controls
• Maintain on-site presence at CDMOs during batch manufacturing to provide real-time guidance
• Oversee clinical supply planning and batch disposition with supply chain and QA partners
• Drive tech transfer plans, manufacturing instructions, and risk assessments
• Enact process improvements through change control and process validation
• Collaborate with internal/external labs on development/characterization for IND/IMPD and BLA/MAA submissions
• Evaluate new technology options for manufacturability and scalability
• Represent manufacturing in cross-functional teams and align with QA on GMP and regulatory filings

Skills

CDMO oversight

Parenteral manufacturing

cGMP knowledge

Quality documentation

Cross-functional collaboration

Education

BS in Chemistry/Engineering/Pharma

MS in relevant field

Job description

Dyne Therapeutics is seeking a Senior Manager, Drug Product Manufacturing, to lead clinical and commercial drug product manufacturing for large molecule parenteral programs at CDMOs. This onsite role in Waltham, MA will drive batch records, deviations, tech transfer, and supply planning across IND/IMPD and BLA/MAA submissions.

The candidate will oversee manufacturing campaigns from pre-IND through commercial with strong cGMP knowledge and proven cross-functional leadership across QA, regulatory,