Associate Director, CMC, Program Management

Role: Associate Director, CMC Program Management, leading strategic and operational oversight of CMC portfolios in a clinical-stage biopharma focused on post-bariatric hypoglycemia, Wolfram syndrome, and ALS. Responsibilities: develop integrated project plans, coordinate cross-functional teams across Regulatory, Quality, Technical Development, and Supply Chain, monitor critical activities, manage risks, and ensure alignment with development and regulatory milestones. Build and maintain governance practices, facilitate decision-making, and improve program management tools. Requirements: Bachelor's in life sciences, chemistry, engineering, or related field; 8-10 years in pharma/biotech project or program management supporting CMC, manufacturing, or product development; strong understanding of CMC development, cGMP, and regulatory compliance; experience managing complex plans and cross-functional teams in matrix environments; excellent communication, organizational, and stakeholder management skills. Preferred: Master’s degree or PMP certification, experience from early development to commercialization, proficiency with tools like Microsoft Project or SharePoint. High-Value: focus on CMC, lifecycle management, technical transfer, process validation; remote work within the U.S. with periodic travel to Cambridge, MA; salary range $178K–$200K.