Sr. Virtual Plant Manager, Biosimilars

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Job DescriptionPrimary contact and relationship manager to specified Contract Manufacturing Organization(s) for the entire relationship. For CMO(s) under her/his responsibility, and in connection with the CMO’s upper management and Biogen representatives of other technology platformsFor CMO(s) under responsibility, lead the cross-functional virtual plant teams consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members.Participate to or lead other matrix teams to drive projects, both internally and externally as they relate to the relevant API or Drug Product operations. Such projects include continuous improvement initiatives, validation activities, regulatory submission reviews etc. and associate change management and/or project management. Initiatives driven can impact multiple supporting line functions and have benefit within and across EM platform areasSupport Sourcing activities in relation with CMO(s) under responsibility. Support the identification and evaluation of potential new CMOs when required as part of Procurement activities.

(Cost negotiations, RFP analysis support, cost savings opportunity identification)Act as backup for the Head of Biosimilar IntegrationDepending on the extent of the portfolio managed by the concerned CMO(s), the holder of the position may coordinate the work of one or more Production Leads, without direct management responsibility.QualificationsBachelors/Master Degree (Life Science, Quality, Engineering), additional competences in Business Administration, Supply Chain or related fields are a plus.7 - 12 years of experience In biotech/pharmaceutical cGMP manufacturing industry.Supplier relationship/interaction experienceDemonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.Good negotiation skills and relationship management skills to foster the appropriate environment with CMO to achieve a professional and agile operational relationshipExperience biologics drug substance manufacturing and fill/finish activitiesPrevious experience in Biosimilar space is a plusAbility to understand technical processes (manufacturing, QC testing), planning and logistics processes, GMP and regulatory requirements and to connect them together in scope of driving the business aspects.Solid business / financial knowledge to manage contracts, disputes.Travel requirements (25% up to 50% maximum)Additional InformationManages one or more complex (multi-site, multi-product, multi-modality, emerging field) CMO(s) for production of biosimilar drug substance and drug product.

Responsibilities include commercial and/or clinical supply. Leads one or several virtual plant teams. Owns contract responsibilities and manages product(s) with one or more CMOs. Owns the overall relationship management for the CMO(s) under responsibility, including when the CMO’s activities encompass work done in several modalities: the Sr Virtual Plant Manager acts as Biogen’s point of contact and negotiation for the global relationship management, interacting with the CMO’s upper management.Is responsible for direct communication with contract site management on production and production issues.Based on size, may be the single management site lead or may have Production Lead(s) helping in the management of production.The position holder is expected to work closely with internal Biogen groups, and to coordinate the corresponding virtual plant team(s) (Quality, Planning, Logistics, Sourcing, Manufacturing Sciences, and Technical Development). Ensures continued supply of Drug Substance and

Drug Product as per clinical and/or commercial demand.Runs the Virtual Plant Team and activities for the CMO(s) under her/his responsibility.Interacts with strategic partnership team for partnered programs.Negotiates MSAs and other contracts in close collaboration with procurement.Ensures projects (product lifecycle management, technology transfers, change control etc.) are smoothly implemented at the CMO and in coordination with concerned Biogen functions.Has financial responsibility for activities performed by the CMO(s) under her/his oversight.Represents External Manufacturing on PO&T asset teamsSummaryType: Full-timeFunction: Manufacturing