Director, CMC Asset Lead

Biogen•Cambridge, MA

7d•Hybrid

About The Position

About This Role The Pharmaceutical Operations and Technology (PO&T) Division is seeking to fill the position of CMC Asset Lead. This role is a key member of the Asset Development & Portfolio Management (ADPM) team, which is responsible for providing cross-functional leadership for development programs, referred to as assets. The PO&T Asset Lead is entrusted with end-to-end leadership across all aspects of asset strategy, development, supply, and life cycle management for the Chemistry, Manufacturing, and Controls (CMC) components of clinical programs in biologics, pharmaceuticals, or other modalities. Specifically, the CMC Asset Lead will oversee one or more programs in pre-clinical to Phase 2 stages and may be required to manage corporate partners. This position is a hybrid role based in Cambridge, MA. What You’ll Do Serve as the PO&T “asset owner” for early-stage programs, with full accountability for developing and delivering a five-year PO&T Asset Strategy, maintaining an 18-month rolling Tactical Plan, monitoring key program risks, and creating risk mitigation plans. Lead the cross-functional PO&T Asset Team, which includes representatives from process and analytical development, manufacturing, quality assurance, supply chain, device (if applicable), and regulatory CMC. Guide the team in developing and implementing both the Asset Strategy and Tactical Plan. Act as PO&T’s representative on Research and Development Program teams, serving as an influencer and liaison between Research, Development, and PO&T leadership. Proactively elevate risks with the Asset Strategy, such as those driven by other assets or line function priorities, by consulting with the PO&T Governance Committee, Research/Development governance, or corporate partners. Monitor the impact of asset-related activities on the annual project budget and resources and total estimated cost to commercialization. Collaborate with PO&T Line Functions to develop tactics for cost improvement and prepare business cases for major asset initiatives, securing management endorsement from the PO&T Governance Committee.\ Maintain program risk register and develop and manage mitigations to keep CMC activities off critical path. Who You Are You are an experienced leader with a deep background in CMC drug development, supply chain, or manufacturing. As a member of ADPM, you will lead teams representing PO&T disciplines and cultivate essential partnerships with Research and/or Development product teams and leaders. Your leadership will be crucial in facilitating and advancing the PO&T vision by overseeing programs as they transition into clinical development. You will promote best practices in resource management and forecasting, oversee decision gates, and support key knowledge management initiatives.

Requirements

An advanced degree (PhD preferable) in a relevant biopharmaceutical discipline with at least 12 years of related experience, including both line and matrix management.
Proven record of effective matrix leadership within program teams through all stages of the product life cycle, such as CMC line function sub-teams or other cross-functional teams in a matrix environment.
Experience with CMC activities spanning research to IND and late-stage development, and a solid understanding of global registration processes.
Technical expertise in one or more areas of bio/pharmaceutical development is required.
Background in the healthcare, biotech, or pharmaceutical industry, with demonstrated understanding of cross-functional interdependencies among Research, Development, commercial, regulatory, and finance functions.
Strong strategic, organizational, and relationship-building skills.
Ability to lead, motivate, and influence strategic direction without direct authority, leveraging and developing diverse perspectives and ideas from matrix teams and other stakeholders.
Excellent communication, negotiation, problem-solving, and decision-making skills.
Demonstrated ability to identify critical program risks and implement strategic or tactical mitigation plans to reduce risk, cost, and reputational impact to Biogen.

Responsibilities

Serve as the PO&T “asset owner” for early-stage programs, with full accountability for developing and delivering a five-year PO&T Asset Strategy, maintaining an 18-month rolling Tactical Plan, monitoring key program risks, and creating risk mitigation plans.
Lead the cross-functional PO&T Asset Team, which includes representatives from process and analytical development, manufacturing, quality assurance, supply chain, device (if applicable), and regulatory CMC.
Guide the team in developing and implementing both the Asset Strategy and Tactical Plan.
Act as PO&T’s representative on Research and Development Program teams, serving as an influencer and liaison between Research, Development, and PO&T leadership.
Proactively elevate risks with the Asset Strategy, such as those driven by other assets or line function priorities, by consulting with the PO&T Governance Committee, Research/Development governance, or corporate partners.
Monitor the impact of asset-related activities on the annual project budget and resources and total estimated cost to commercialization.
Collaborate with PO&T Line Functions to develop tactics for cost improvement and prepare business cases for major asset initiatives, securing management endorsement from the PO&T Governance Committee.
Maintain program risk register and develop and manage mitigations to keep CMC activities off critical path.

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