CMC Asset Lead, Associate Director

About This Role

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership of development programs (assets). The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for all CMC aspects of clinical programs in biologics, pharmaceuticals or other modalities.

This PO&T Asset Lead role is specifically responsible for leading CMC of one or more clinical immunology programs. Programs may require alliance management of corporate partners.

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership of development programs (assets). The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for all CMC aspects of clinical programs in biologics, pharmaceuticals or other modalities.

This PO&T Asset Lead role is specifically responsible for leading CMC of one or more clinical immunology programs. Programs may require alliance management of corporate partners.

This is a hybrid role based in Cambridge, MA.

• Serve as the PO&T “asset owner” of clinical programs, with accountability for delivering a 5-year PO&T Asset Strategy, maintenance of an 18-month rolling Tactical Plan, monitoring key program risks and development of risk mitigation plans
• Lead the cross-functional PO&T Asset Team including representatives from process/analytical development, manufacturing, quality, supply chain, device (if applicable) and regulatory CMC, in the development of and delivery on the PO&T Asset Strategy & Tactical Plan
• Serve as PO&T’s representative on the Research and Development Program teams; acts as in influencer and liaison between Research, Development and PO&T leadership.
• Proactively manage conflicts with the Asset Strategy (e.g., driven by other Assets and/or Line Function priorities) in consultation with the PO&T Governance Committee, Research/Development governance, or corporate partners.
• Monitor asset-related impacts on the annual project budget and resources and cost to commercialization (e.g., expenses, COGS, excess production, OPEX) and collaborate with the PO&T Line Functions to develop tactics to improve them. Develop business cases for key asset initiatives and secure management endorsement at the PO&T Governance Committee

You have leadership experience in CMC drug development, supply chain or manufacturing. You will be part of ADPM and lead teams representing PO&T disciplines and maintaining critical partnerships with relevant program Research and/or Development product teams and leaders. You will be instrumental in leading and facilitating key aspects of the PO&T vision through engagement/oversight of programs transitioning into clinical development, driving best practices for resource management/forecasting, decision gates and associated knowledge management initiatives.

• Advanced degree (PhD preferred) in a relevant biopharmaceutical discipline, and 8 years of relevant experience including line and matrix management. MS, MBA and/or Bachelor’s degree may be considered with commensurate experience.
• Experience in matrix leadership experience in the setting of program teams across the full product life cycle, e.g., (CMC) PO&T line functions sub-teams or other cross-functional teams operating in a…