Associate Director, Drug Product Manufacturing

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 a 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. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

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 Include :

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

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MA Pay Range

$160,000 $196,000 USD

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 orien…