CMC Asset Lead

Biogen•Cambridge, MA

11h•Hybrid

About The Position

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.

Requirements

Leadership experience in CMC drug development, supply chain or manufacturing.
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.
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 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.

Responsibilities

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

Benefits

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