Senior Director, Drug Product Manufacturing

Senior Director, Drug Product Manufacturing

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and 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 Senior Director, Drug Product Manufacturing will be accountable for all activities related to successful development and manufacturing operations and drug product related activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless supply of all drug product for clinical trials and will lead efforts for drug product commercial readiness and launch. This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

• Act as the subject matter expert in drug product development including formulation, container closure and sterile fill finish manufacturing
• Act as main point of contact for CDMO(s) including leading CDMO working teams and strategic business review chairperson
• Responsible for tech transfer, scale-up and cGMP manufacturing of drug product including PPQs
• Responsible for ensuring uninterrupted drug product supply for clinical studies, commercial readiness and launch
• Key contributor to drug product sections of BLAs/NDAs/INDs/IMPDs
• Collaborate with CMC, Quality Control, Quality Assurance, and Clinical Operations to ensure continuity of drug supply
• Responsible for driving execution of the production plan at CDMO (PO through delivery)
• Working with CMC, Legal, and Strategic Sourcing take the lead in identification and resolution of business/contract issues and supply agreements
• Partners with CMC, Quality and Regulatory to champion a culture of quality with our CDMO's and to ensure that all activities and documentation comply with regulatory requirements
• Partner with Strategic Sourcing to develop and implement long term external manufacturing strategies that provide a reliable, robust, and cost-effective manufacturing network
• Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration

Education and Skills Requirements:

• Bachelor's degree in science, chemical engineering or related field, or equivalent with 12+ years of related work experience, or advanced degree and a minimum of 8 years of work experience.
• Proven experience in clinical and commercial drug product formulation development including liquid fill finish, lyophilization and other injectables.
• Expertise in sterile fill finish manufacturing as well as understanding of analytical techniques that support manufacturing activities.
• Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.
• Strong experience and knowledge of cGMP manufacturing requirements and experience in PPQ planning and execution to support BLAs/NDAs.
• Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments.
• Ability to work, influence, and gain consensus across multiple functions (CMC, Quality and Regulatory Affairs).
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes.
• Strong analytical, problem solving and critical thinking skills.
• Expertise in use of MS Excel, as well as demonstrated proficiencies in Smartsheet, Visio, ERP systems and Power BI (or similar application).
• Collaborative work style to be part of a team to identify process gaps and develop solutions.
• Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise-wide, from the executive team to the manufacturing floor.
• Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.