CMC Asset Lead

This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

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 across PO&T’s line functions. 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 biopharmaceutical programs. This PO&T Asset Lead role is specifically responsible for leading CMC of one or more clinical programs. Late-stage programs require management of corporate partnership contributions to product commercialization, including management of joint manufacturing committees, and planning life cycle management activities.

This is a hybrid role to be based at our headquarters in Cambridge, MA.

What You’ll Do

• Serve as the PO&T “asset owner” of clinical biologics 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 (i.e., including representatives from each PO&T Line Function) in the development of and delivery on the PO&T Asset Strategy & Tactical Plan
• Serve as PO&T’s representative on the R&D Program teams and Commercial teams; acts as in influencer and liaison between R&D, Commercial and PO&T leadership.
• Key contact to partner companies co-developing late-stage biologics. CMC leadership of asset requires influencing of partner company through management of joint-CMC meetings and joint collaboration governance
• 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/Commercial governance, or corporate partners.
• Monitor asset-related impacts on the P&L (e.g., COGS, E&O, 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
  
  

Qualifications

Who You Are

You are a seasoned leader with in-depth experience in 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 R&D and/or product commercial leaders. You will be instrumental in leading and facilitating key aspects of the PO&T vision through engagement/oversight of partner-company collaborations, driving best practices for resource management/forecasting, decision gates and associated knowledge management initiatives.

Qualifications

• Bachelor’s degree and a minimum of 12 years of relevant experience with a focus on matrix management. Advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline.
• Track record of effective 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 ideally across an organization
• Experience with CMC, supply chain, or LCM development extending from IND to NDA/BLA, including a solid understanding of global registration processes. Technical expertise in one or more relevant biopharmaceutical development disciplines
• Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory)
• Excellent strategic, political, 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.
• Excellent 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.
  
  

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.