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Senior Manager Manufacturing - USP (a)

Senior Manager Manufacturing - USP (a)

Michael PageSolothurn, CH
Vor 30+ Tagen
Stellenbeschreibung

The Manufacturing Expert will be responsible for technical and scientific support to manufacturing (MFG) shopfloor and will manage timely completion of MFG activities (compliance, TT, campaign preparation, troubleshooting…). The responsibilities will be around the following task areas :

  • Acting as Subject Matter Expert on manufacturing equipment and automated processes (Upstream Drug Substance Biologics)
  • Partnering with direct manager to assign appropriate resources to tech transfers, drive continuous improvement, ensure manufacturing instructions are clear, safe, and compliant
  • Opportunity to coach and train cross functionally to meet career goals and business objectives AND to be individual contributor with respect to technical instruction management for specific portions of a manufacturing process
  • Initiating, owning, and managing Manufacturing focused Change Controls, CAPAs, and Planned Exceptions
  • Continuous improvement and Coaching of Manufacturing Associates regarding main area of expertise and side processes
  • Increasing productivity - managing intra, cross-site, and cross-functional projects related to process and productivity improvements

In order to be considered for the role, the selected candidate must have :

  • Bachelor or higher degree in Engineering or related field
  • 8+ years work experience within GMP environment
  • Upstream Experience ideally for Drug Substance of Biologics
  • Strong manufacturing / technical process knowledge and / or strong knowledge of scientific principles
  • Strong understanding of basic QA and cGMP principles
  • Coaching and Trainer skills for Manufacturing related activities (as Deputy to the MTO Manager)
  • DeltaV experience is a MUST, Syncade is a nice to have
  • Strong documentation and communication skills in English to interact with a cross-functional team effectively

    • The selected candidate will be part of a dynamic team and actively contribute to the discovery, development and delivery of innovative therapies to improve the lives of patients.