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Marketing Manager Start up

vor 1 Monat

Stäfa, Schweiz Homberger Personalberatung Vollzeit

The Packaging Engineer will be in charge of the coordination of packaging with commercial drug product Contract Manufacturing Organizations (CMOs), and other third-party suppliers for small molecule products:

The candidate will be responsible for the following tasks areas:

  • SME for primary and secondary packaging (for small molecules)
  • Develops and maintains good working relationships with contract manufacturers
  • 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.
  • Prepares Annual Product Reports with Manufacturing CMOs according to the company’s needs
  • Works with CMOs and company participants to schedule and coordinate Steering Committee Meetings
  • Works with Quality Group and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
  • With Quality Assurance, ensures CMOs remain current and compliant with all GMP-related requirements, guidelines, and procedures
  • 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

The successful candidate must have:

  • Bachelor's degree or higher in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience
  • 5-10 years of progressively responsible experience as packaging engineer for small molecules is an absolute must
  • Strong technical understanding of the biopharmaceutical packaging process
  • 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
  • Good 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
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