Director, CMC Project Management

Role: The Director of CMC Project Management oversees end-to-end CMC project execution for biologics in a fast-paced biotech setting, ensuring strategic and operational alignment across process development, manufacturing, supply chain, quality, and regulatory functions. Responsibilities: lead integrated CMC project plans, manage cross-functional teams, liaise with external vendors and CDMOs, monitor program progress, and utilize AI tools for risk and visibility management. Requirements: MS or BS in a scientific or engineering discipline; 10+ years of relevant experience with at least 6 years managing biologics CMC programs; strong understanding of biologics development, manufacturing, and regulations; experience with external partnerships and AI-enabled project management. Preferred: PMP certification; familiarity with project management platforms and data visualization; prior success in lean operational environments and cross-functional stakeholder engagement. High-Value: biologics, CMC development, external vendor management, AI tools, regulatory compliance, and experience operating in a small-team, agile biotech environment. Work setup: remote with occasional travel or hybrid in Cambridge, MA.