CMC Asset Lead

About This Role

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This 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.

What You'll Do

• 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

• Advanced degree (PhD) preferred in a relevant biopharmaceutical discipline, and 10 years of relevant experience including line and matrix management. MS, MBA and/or Bachelor's degree may be considered with extensive 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 matrix environment.
• Experience with CMC in one or more areas from research to IND to NDA/BLA,. Technical expertise in one or more relevant bio/pharmaceutical development discipline.
• Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., Research, Development, commercial, regulatory, finance)
• Excellent strategic, organizational, and relationship development skills
• Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
• Demonstrated communication, negotiation, problem solving and decision-making abilities
• Demonstrated ability to identify critical program risks and develop mitigation plans - strategic or tactical - to mitigate risk, costs, and reputation of Biogen.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation