Commercial CMC Asset Lead

vor 2 Monaten


Baar, Schweiz Biogen Vollzeit
Job Description

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

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.

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 maintain 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 including Influence & Collaborations through engagement with/oversight of collaborations and interface with BD and External Innovation; Data Access and Connectivity by driving best practices for resource management/forecasting decision gates and associated knowledge management initiatives.



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.

 



  • Baar, Zug, Schweiz Biogen Vollzeit

    About This RoleWe are seeking a seasoned leader to join our Pharmaceutical Operations and Technology (PO&T) Division as a Commercial CMC Asset Lead. This role is a key member of the Asset Development & Portfolio Management (ADPM) team, responsible for providing cross-functional leadership across PO&T's line functions for an asset.The Commercial CMC Asset...


  • Baar, Schweiz Biogen Vollzeit

    **Job Description** 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...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About This RoleWe are seeking a seasoned leader to join our Asset Development and Portfolio Management (ADPM) team as a Commercial CMC Asset Lead. This role is responsible for leading a commercial asset and all life cycle management activities, including asset strategy, development, supply, and life cycle management planning.Key ResponsibilitiesDevelop and...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About This RoleBiogen is seeking a seasoned leader to join our Asset Development & Portfolio Management (ADPM) team as a Commercial CMC Asset Lead. This role is responsible for leading a commercial asset and all life cycle management activities, including asset strategy, development, supply, and life cycle management planning.Key ResponsibilitiesDevelop and...


  • Baar, Schweiz Biogen Idec Vollzeit

    Job DescriptionAbout 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...


  • Baar, Schweiz Biogen Vollzeit

    Job Description 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...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About This RoleThe Pharmaceutical Operations and Technology (PO&T) Division is seeking a seasoned leader to fill the Commercial Asset Lead position. As a key member of the Asset Development & Portfolio Management (ADPM) team, this individual will provide cross-functional leadership across PO&T's line functions for an asset.Key ResponsibilitiesDevelop and...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About This RoleThe Pharmaceutical Operations and Technology (PO&T) Division is seeking a seasoned leader to fill the Commercial Asset Lead position. As a key member of the Asset Development & Portfolio Management (ADPM) team, this individual will provide cross-functional leadership across PO&T's line functions for an asset.Key ResponsibilitiesDevelop and...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About This RoleThe Pharmaceutical Operations and Technology (PO&T) Division is seeking a seasoned leader to fill the Commercial CMC Asset Lead position. This role is a key member of the Asset Development & Portfolio Management (ADPM) team, providing cross-functional leadership across PO&T's line functions for an asset.Key ResponsibilitiesDevelop and deliver...


  • Baar, Schweiz Biogen Vollzeit

    The Pharmaceutical Operations & Technology Division (PO&T) is looking to hire a Director, Commercial Asset Leader. The PO&T Commercial Asset Leader is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership across PO&T’s line functions for Biogen’s assets. The PO&T Commercial Asset Leader is...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About the RoleWe are seeking a highly skilled Senior Manager, Regulatory CMC Lead to join our team at Biogen. In this role, you will be responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products.Key...


  • Baar, Schweiz Biogen Idec Vollzeit

    Job DescriptionAbout the roleIn this role you are responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific small molecule...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About the RoleIn this pivotal position, you will provide expert Regulatory CMC guidance to shape the global regulatory strategy, operations, and planning for assigned projects/products. Your responsibilities will include preparing and compiling submission/documentation for small molecule projects, collaborating with the Regulatory CMC Lead and key...


  • Baar, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** The commercial head of ADPM will elevate issues to the PO&T Governance Committee as appropriate and will be responsible for supply risk management. This role will represent PO&T at appropriate joint steering and joint manufacturing committees. Assets will transition to the head of commercial ADPM once products are...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About this roleThe Regulatory CMC Small Molecules Team Lead will be responsible for leading a team of regulatory professionals in the development and implementation of global CMC regulatory strategies for small molecule products. This role will require strong leadership and communication skills, as well as the ability to work effectively in a matrixed...


  • Baar, Zug, Schweiz Biogen Idec Vollzeit

    About the RoleIn this position, you will provide Regulatory CMC expertise to support the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products. Your responsibilities will include preparation and compilation of submission/documentation for specific small molecule projects,...


  • Baar, Zug, Schweiz Biogen Vollzeit

    About this roleJoin Biogen's Regulatory CMC TeamAs a key member of our Regulatory CMC team, you will be responsible for leading the small molecule portfolio and ensuring the timely approvals of clinical trial applications, initial marketing authorization applications, and lifecycle changes.Key ResponsibilitiesLead the development of working processes and...


  • Baar, Schweiz Biogen Vollzeit

    **Job Description**: **About this role**: Supply Chain Planning Lead is a challenging and highly visible role that serves as the primary interface within and between PO&T (Pharmaceutical Operations & Technology) and Commercial Business organization for commercial demand/supply product planning. You ensure business continuity and uninterrupted, efficient drug...


  • Baar, Schweiz Biogen Vollzeit

    Job DescriptionAbout this roleThe role can be US based hybrid in Cambridge or RTP or Baar based in SwitzerlandAs Regulatory CMC Small Molecules Team Lead you are responsible for the line management of direct reports, with responsibilities for the  small molecule portfolio. The Regulatory CMC Team Lead with the Regulatory CMC Global Regulatory Lead (RegCMC...

  • E2e PLCm Product Planner

    vor 5 Monaten


    Baar, Schweiz Biogen Vollzeit

    **Job Description** About the role** **Location Baar** - PLCM change coordinator of GCC and Artwork for Biogen commercial products. Responsibilities also include oversight of Drug Substance (DS) and Drug Product (DP) global change control impacting Finished Goods (FG) for a brand in growth phase. - Ensures alignment of artwork with the technical...