Commercial CMC Asset Lead

at  Biogen

Baar, ZG, Switzerland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Dec, 2024Not Specified29 Sep, 2024N/AProduct Life Cycle,Ind,Matrix Management,Supply Chain,Risk,Negotiation,CmcNoNo
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Description:

Job Description

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 a relevant biopharmaceutical development discipline
  • 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.

Responsibilities:

ABOUT THIS ROLE

The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a Commercial 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 for an asset. The Commercial CMC Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for the commercial program. This PO&T Asset Lead role is specifically responsible for leading a commercial asset and all life cycle management activities.
This is a hybrid role that could be based in Cambridge, MA or Baar, Switzerland.

WHAT YOU’LL DO

  • Serve as the PO&T “asset owner” 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 PDC teams; acts as in influencer and liaison between R&D, Commercial and PO&T in support on asset(s).
  • 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. Ensure alignment and accountability of PO&T Line Functions for providing support for their needs balanced with the needs of the Asset Strategy.
  • 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


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

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Baar, ZG, Switzerland