Dyne Therapeutics · 1 day ago
Senior Director, Drug Substance Manufacturing
Waltham, MA
Full-time
Onsite
Director/Executive
$217K/yr - $267K/yr
12+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Senior Director, Drug Substance Manufacturing is responsible for leading GMP drug substance manufacturing and overseeing all CMC activities related to Fab-oligonucleotide conjugates, ensuring commercial supply and effective management of Dyne’s complex clinical supply chain.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Responsible for bioconjugation activities including validation, characterization, scale-up, clinical and commercial manufacturing
Establish and manage contracts, supply agreements and CDMOs
Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
Work closely with CMC Technical Development to support bioconjugation improvement activities and enhance the tech transfer process
Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions
Support the development of regulatory CMC documentation and partner due diligence
Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes
Provide patents and creative ideas to provide protection or creation of new or better products or processes
Qualification
Required
Bachelor's degree in biology, biochemistry, chemistry, or a related scientific field required; advanced degree preferred
Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management and oversight of complex development programs
Proven expertise in bioconjugates, as well as strong knowledge of biologics and small molecule manufacturing, materials management, quality control/assurance, and CMC regulatory requirements
Demonstrated experience in leading contract manufacturing and managing external partners such as CDMOs and CTLs
Comprehensive experience with CMC regulatory submissions across all phases of development, ideally including post-approval activities, global regulatory interactions, and negotiations with health authorities on CMC issues related to biologic APIs
Strong understanding of processes and systems supporting biopharmaceutical development, with the ability to challenge current practices and drive continuous improvement
Exceptional leadership and interpersonal skills, including the ability to influence without authority, motivate teams, and collaborate effectively across functions and organizational levels
Highly organized with demonstrated ability to prioritize workload, manage multiple programs in a fast-paced, deadline-driven environment, and consistently deliver on objectives
Skilled in strategic thinking and problem-solving, with the ability to evaluate options, identify pros and cons, and implement creative solutions
Excellent communication and negotiation skills, capable of building consensus and achieving win-win outcomes across diverse stakeholders
Self-directed and adaptable, able to work independently with limited guidance in a complex and evolving environment
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2026-01-11
2026-01-07
2025-12-24
Company data provided by crunchbase