Senior Manager Drug Product 80-100%

vor 1 Tag

Baar, Schweiz TN Switzerland Vollzeit

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Job Reference:

e006f36d6f2f

Job Views:

6

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

The Senior Manager DP Manufacturing will be the technical lead and primary contact responsible for managing commercial DP Contract Manufacturing Organizations (CMOs) and other third-party suppliers, mainly overseeing the tech transfer from the US to Europe in 2025.

The candidate will be responsible for the following tasks:

  • Co-leads manufacturing activities and coordinates activities across a matrix team. A Subject Matter Expert (SME) in DP manufacturing with extensive knowledge in development, quality, and regulatory requirements for manufacturing.
  • Manages all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs, Protocols, QRAs, etc.), including oversight of manufacturing operations, tech transfer, managing deviations, investigations, and relevant change actions, supporting product release, and ensuring the finished product arrives in the warehouse for distribution.
  • Responsible for the DP vendor selection process for new commercial suppliers or alternative suppliers, as well as maintaining good work relationships with existing ones.
  • Develops and maintains a DP manufacturing production timeline that is resource and budget loaded to ensure near real-time tracking of production and resources.
  • Coordinates periodic CMO Manufacturing meetings, preparing minutes and tracking completion of action items.
  • Maintains and follows through a consolidated Manufacturing action log to ensure all manufacturing-related actions are completed on time.
  • Provides onsite process coverage as person-in-plant as needed.
  • Develops and collects appropriate internal and external metrics to measure CMO and company performance.
  • Communicates manufacturing or technology-related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
  • Prepares Annual Product Reports with Manufacturing CMOs according to needs.
  • Collaborates with CMOs and colleagues to schedule and coordinate Steering Committee Meetings.
  • Collaborates with Quality and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure compliance with GMP and timely resolution and closure.

The successful candidate must have:

  • Bachelor's degree or higher in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience.
  • 5+ years of progressively responsible experience in Drug Product Manufacturing Commercial Phase (Small Molecules) is a must.
  • Strong understanding of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits.
  • Extensive knowledge of current Good Manufacturing Practices (cGMPs).
  • Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
  • Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
  • Outstanding communicator: clear, concise, well organized, and appropriate to the audience.
  • Business fluency in English; additionally, German and/or French is a plus.
  • Domestic and International travel is required for this role (30%).
  • Modern working environment with state-of-the-art facilities and technologies.
  • Challenging assignments in a fast-growing and innovative industry.
  • Position in a dynamic, international team of highly skilled professionals.
  • Hybrid work option (3 days onsite, 2 days HO).
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