Director, CMC Management
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:
Director, CMC Management will be accountable for project and portfolio management activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless development of CMC plans for Dyne projects towards commercial readiness.
This role is based in Waltham, MA.
Primary Responsibilities Include (but limited to):
- Lead project and portfolio management function to develop CMC timelines, risk register, budgets working with CMC teams (collaborate with CMC, Supply, Quality Control, Quality Assurance, and Clinical Operations)
- Act as main point of contact for CMC team leaders including working subteams and strategic business teams
- Responsible for supporting CMC teams with long term strategic plans including LRP, budget planning and timelines across the portfolio
- Prepare management review presentations with expertise in Smartsheets or MS Project
- Develop and maintain dashboards, Sharepoint folders and repository for CMC plans for each program
- Support CTO with LRP, timelines and budget planning across Tech Ops/CMC
- Act as collaboration point of contact with Dyne PMO and program managers
- Organize and maintain documentation related to project plans
- Support Reg CMC with submission timelines e.g. reviews, approvals internally within CMC
- Champion a strong winning culture, fostering teamwork and commitment to excellent through transparent communication, engagement and collaboration
Education and Skills Requirements:
- Bachelor’s Degree in Science or related field, or equivalent with 8-10 years of related work experience, or advanced degree and a minimum of 6 years of work experience
- Project and portfolio management certificate or expertise; deep knowledge of project management tools e.g. Smart sheet, MS Project, dashboards
- 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; highly organized.
- 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
#LI-Onsite
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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