Associate Director, Drug Product Manufacturing

jobr.pro; Waltham (MA); On-site; USD 210,000 - 260,000; Full time

Job summary

Dyne Therapeutics is seeking an Associate Director, Drug Product Manufacturing in Waltham, MA to lead clinical and commercial parenteral manufacturing programs and serve as the primary technical owner at CDMOs across campaigns from pre-IND through commercial. This role ensures scalable, compliant processes aligned with Dyne’s FORCE platform.

You will drive day‑to‑day manufacturing activities, oversee batch records and deviations, lead tech transfer and continuous improvement, and collaborate

Qualifications

• BS in Chemistry, Chemical Engineering, or Pharmaceutical Sciences; MS/PhD preferred
• Experience with parenteral drug product manufacturing and CDMO oversight
• Strong knowledge of sterile fill–finish operations
• Experience with batch records, deviations and tech transfer
• Good understanding of cGMP/regulatory expectations (FDA, EMA)

Responsibilities

• Lead clinical and commercial drug product manufacturing activities for large molecule, sterile injectable programs (liquid and lyophilized)
• Serve as primary technical owner for drug product manufacturing at CDMOs, guiding campaigns from pre-IND through commercial
• Drive day‑to‑day manufacturing activities and prepare/review batch records
• Maintain on‑site presence at CDMOs during campaigns to ensure quality and provide real‑time technical guidance
• Oversee batch disposition activities with QA
• Lead investigations of deviations, CAPAs, and change controls
• Identify and implement process improvements through change control and validation
• Drive tech transfer activities with internal and external partners
• Partner on process development and characterization to support regulatory submissions (IND/IMPD, BLA/MAA)
• Ensure manufacturing processes align with clinical and commercial needs
• Represent manufacturing on cross‑functional teams; communicate status, risks, mitigation
• Collaborate with QA for GMP alignment
• Coordinate with supply chain for clinical supply continuity
• Author/review technical reports and regulatory submission sections

Skills

CDMO oversight

Sterile manufacturing

Batch records

Tech transfer

cGMP knowledge

Troubleshooting

Cross-functional collaboration

Communication skills

Program management

Regulatory readiness

Education

Chemistry/Chem Eng/Pharm Sci degree

Job description

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

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.

This position is based in Waltham, MA.

Primary Responsibilities

Drug Product Manufacturing Execution & Oversight

• 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

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job‑related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all‑inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.