Senior Director, Drug Substance Manufacturing

Role Summary

The Senior Director, Drug Substance Manufacturing is responsible for leading GMP drug substance manufacturing, process performance qualification (PPQ), ensuring commercial supply, and overseeing all CMC activities related to Fab-oligonucleotide conjugates (drug substance). This role includes strategic vendor management for commercial drug substance production and coordination of external development and manufacturing activities with contract development and manufacturing organizations (CDMOs), contract testing laboratories (CTLs), and other key suppliers.

This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne's complex clinical supply chain and support eventual launch and commercialization efforts.

This role is based in Waltham, MA.

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

Qualifications

• Required: Bachelor's degree in biology, biochemistry, chemistry, or a related scientific field; advanced degree preferred.
• Required: Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management and oversight of complex development programs.
• Required: Proven expertise in bioconjugates, with strong knowledge of biologics and small molecule manufacturing, materials management, quality control/assurance, and CMC regulatory requirements.
• Required: Demonstrated experience in leading contract manufacturing and managing external partners such as CDMOs and CTLs.
• Required: 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.
• Required: Strong understanding of processes and systems supporting biopharmaceutical development, with the ability to challenge current practices and drive continuous improvement.
• Required: Exceptional leadership and interpersonal skills, including the ability to influence without authority, motivate teams, and collaborate effectively across functions and organizational levels.
• Required: Highly organized with demonstrated ability to prioritize workload, manage multiple programs in a fast-paced, deadline-driven environment, and consistently deliver on objectives.
• Required: Skilled in strategic thinking and problem-solving, with the ability to evaluate options, identify pros and cons, and implement creative solutions.
• Required: Excellent communication and negotiation skills, capable of building consensus and achieving win-win outcomes across diverse stakeholders.
• Required: Self-directed and adaptable, able to work independently with limited guidance in a complex and evolving environment.