Director, CMC Management

New Yesterday

Director, CMC Management 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, and budgets working with CMC teams. Act as the 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.
Location:
Waltham, MA, United States
Job Type:
FullTime
Category:
Management Occupations

We found some similar jobs based on your search