Senior Manufacturing Scientist, Manufacturing Sciences
Biogen
Baar, Canton of Zug, Switzerland
vor 5 Tg.
Job Description

  • Access and implement manufacturing processes changes to existing processes
  • Manage process validation activities
  • Transfer and document manufacturing processes
  • Author regulatory documentation
  • Implement CAPAs
  • Access new technologies
  • Represent GMS on Asset Teams
  • Execution and technical leadership in process transfers and improvements
    Lead technical area and process issue troubleshooting
  • Responsible for manufacturing processes and its robustness
  • Lead/Participate on projects and collaborations
  • Consult with supervisors, project leaders, external partners to align on strategy direction of activities and decisions, 
  • Understand the complexity of issues and defines resolution plans in regards to business needs
  • Responsible for making a product impact decision 
  • Interact with CMOs, on technical and Manufacturing issues
  • Influence decisions in regards to technical expertise (e.g. Influence selection of CMOs)
  • Highlight and make other business functions aware of technical /process/Product risks

Qualifications

  • 10+ years business experience ideally in pharmaceutical or Biotech industry (drug substance/product manufacturing and process engineering)
  • Advanced university degree in Biotech, Chemistry, Pharmaceutical Technology or similar Science
  • Advanced knowledge and expertise in biopharmaceutical drug substance development and manufacturing technologies, process scale up and transfers and commercial manufacturing support 
  • Ability to provide technical leadership in experimental design set up (DOEs), PPQ and CPV design and execution, trouble shooting, can lead junior scientists
  • Thorough understanding of the common analytical techniques, and ability to set specification for in-process-controls, release and stability indicating parameters 
  • Experience in process data evaluation, and capacity to apply general statistical tools
  • Teamplayer with strong communication & presentation skills
  • Knowledge of the latest GMP and pharmaceutical guidelines
  • Fluency in English, any other language is an asset


Additional Information

The Senior Manufacturing Scientist function provides the technical leadership in regards to drug substance manufacturing and drug product manufacturing at external partners including technical transfers, providing regulatory relevant manufacturing documents, trouble shooting and process improvements. The person works in the Global Manufacturing Science team responsible for all external/CMO activities mainly based in Baar and works closely with internal key functions like technical development, quality, manufacturing operations, regulatory, planning.

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