- You will be the primary contact and relationship manager to specified Contract Manufacturing Organization(s) for the entire relationship
- For CMO(s) under responsibility, you will lead the cross-functional virtual plant teams consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members.
- You will participate to or lead other matrix teams to drive projects, both internally and externally as they relate to the relevant API, Drug Product, device assembly or labelling and packaging operations. Such projects include continuous improvement initiatives, validation activities, packaging changes, regulatory submission reviews etc. and associate change management and/or project management.
- You will support Sourcing activities in relation with CMO(s) under responsibility. (Cost negotiations, RFP analysis support, cost savings opportunity identification)
- Act as backup for the Head of Pharmaceutical Products or Parenteral Products or Device Assembly, Labelling and Packaging or Early Stage Clinical and New Manufacturing Platforms.
- Depending on the extent of the portfolio managed by the concerned CMO(s), you may coordinate the work of one or more Production Leads, without direct management responsibility.
- You hold a Bachelor/Master Degree (Life Science, Quality, Engineering), additional competences in Business Administration, Supply Chain or related fields are a plus.
- You have minimum 5 - 7 years of experience In biotech/pharmaceutical cGMP manufacturing industry. Supplier relationship/interaction and packaging experience are must have to succeed in this role.
- You own demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.
- Strong negotiation skills
- Ideally, you possess experience with either biologics and oral solid dosage manufacturing including a mix of parenteral filling, API, oral solid dosage and finished products manufacturing.
- Responsibilities include commercial and/or clinical supply. Lead one or several virtual plant teams, own contract responsibilities and manage product(s) with one or more CMOs
- Be responsible for direct communication with contract site management on production and production issues.
- Work closely with internal Biogen groups to coordinate the corresponding virtual plant team(s) (Quality, Planning, Logistics, Sourcing, Manufacturing Sciences, and Technical Development). Ensures continued supply of API / Drug Product / Finished Product as per clinical and/or commercial demand.
- Lead without authority, run the Virtual Plant Team and activities for the CMO(s) under your responsibility.
- Ensure projects (product lifecycle management, technology transfers, change control etc.) are smoothly implemented at the CMO and in coordination with concerned Biogen functions
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