Senior Analytical Transfer Specialist

Vor 7 Tagen

Lausanne, Waadt, Schweiz Axepta SA Vollzeit
About the Role

Axepta SA is seeking a highly skilled Senior Analytical Transfer Specialist to join our team in the QC Operations department of our northern Vaud site. As a key member of our team, you will be responsible for leading comprehensive validation studies to evaluate the performance of analytical methods, ensuring alignment with regulatory guidelines and Good Manufacturing Practices (GMP).

Key Responsibilities
  • Lead Validation Studies: Develop, review, and approve analytical transfer, validation, and verification protocols, data, reports, test methods, and related documentation.
  • Technical Expertise: Interpret and analyze validation study results, preparing detailed and comprehensive reports.
  • Collaboration and Communication: Serve as the analytical technical expert on multiple programs, collaborating with internal and external team members to advance projects. Work closely with Program Management to establish clear expectations and achieve successful outcomes.
  • Method Development: Provide expertise in analytical methods development for product development programs.
  • Platform Laboratory: Contribute to establishing a platform laboratory to ensure the rapid implementation of new methods in product development programs.
  • Resource Management: Assist in budget definition and tracking, and identify resource needs for activities under your responsibility.
  • External Collaboration: Coordinate with external laboratories, if applicable, to ensure effective collaboration, cost management, and timeline adherence.
  • Regulatory Compliance: Oversee the implementation of new raw materials by defining necessary tests in alignment with pharmacopeial standards.
  • Subject Matter Expert: Act as a Subject Matter Expert (SME) and participate in internal/external audits and Health Authority (HA) inspections related to method validation/transfer.
  • Regulatory Monitoring: Conduct regulatory and technical monitoring to ensure compliance with evolving industry requirements.
Requirements
  • Scientific Background: Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment.
  • Experience: Ideally between 8-10 years' experience in project management, analytical transfer and analytical validation.
  • Technical Skills: Strong understanding of Elisa, Virology, Microbiology, PCR.
  • Regulatory Knowledge: Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification.
  • Language: Fluent in French and English.

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