Senior Director, Drug Product Manufacturing
Department: 110 CMCLocation: Waltham, MA
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 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. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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.
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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.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
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.
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