Hiring: Pioneering Medicines: Executive Director, CMC (Chemistry, Manufacturing & Controls) Company: Flagship Pioneering Location: Cambridge, MA Job Posted Time: 2026-09-09 17:58:09 Employment Type: Full-time Target Skills & Keywords: CMC Strategy, Technical Operations, Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development, Regulatory CMC, Emerging Modalities, Multimodality Pipeline, CDMO Network Management, AI-Enabled CMC Tools, Portfolio Management, Cross-Functional Leadership, Talent Development Experience: - Proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously - Senior leadership experience operating at the intersection of science, strategy, and operations - Experience owning CMC across the full portfolio from research interface through early and late clinical development - Experience building and scaling a CMC organization and defining its strategic direction - Experience building and managing external CDMO networks, including selection, assessment, and establishment of strategic relationships - Experience with portfolio-level resourcing decisions and CMC risk identification, prioritization, and mitigation Required Skills: - Ability to set direction across a complex multimodality pipeline - Capability to build CMC function as a competitive advantage - Equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level - Defining approaches for emerging modalities - Building and leveraging a best-in-class external CDMO network - Strategic acumen for portfolio-level resourcing decisions - Thought leadership in innovative approaches - Championing adoption of AI-enabled CMC tools - Leading CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development, and Regulatory CMC - Recruiting, developing, and retaining a high-performing CMC team - Cultivating a culture of excellence, accountability, and continuous improvement - Driving end-to-end CMC execution across an increasing portfolio of multimodality compounds - Ensuring programs advance on time and on strategy - Maintaining a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs - Overseeing identification, evaluation, and implementation of novel technologies and innovations - Leveraging emerging AI-driven technical development, manufacturing, and advanced analytics approaches - Engaging and aligning key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs - Establishing CMC development paradigms and resolving cross-functional trade-offs Qualifications: - Senior leadership experience in CMC within the biopharmaceutical industry - Demonstrated ability to lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development, and Regulatory CMC - Proven ability to build, scale, and lead high-performing teams - Strong track record of managing external CDMO partnerships - Experience across emerging modalities and multimodality programs - Ability to operate at both strategic portfolio level and hands-on program level - Strong cross-functional stakeholder engagement and alignment skills Compensation: Not specified Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don’t miss this opportunity to join a forward-thinking team!