Analytical Transfer and Validation Senior Specialist

vor 1 Woche


YverdonlesBains, Waadt, Schweiz Incyte Vollzeit
Job Overview

This position supports the transfer and validation of analytical methods and all analytical activities related to the product life cycle, from raw materials to DS & DP testing. As a Subject Matter Expert (SME), the Specialist/Senior Specialist - Analytical Transfer & Validation will act as a technical expert on multiple programs, collaborating with internal and external team members to move projects forward.

Key Responsibilities:
  • Manage comprehensive validation studies to assess the performance of analytical methods, in accordance with regulatory guidelines and Good Manufacturing Practices.
  • Write, review, and implement analytical transfer/validation/verification protocols, data, reports, test methods, and other related documentations.
  • Analyze and interpret results of validation studies and prepare detailed reports.
  • Collaborate with internal and external team members to move projects forward and ensure clear expectations and successful results.
  • Support the budget definition and tracking, definition of resource needs for execution of activities under his/her responsibilities.
  • Manage external laboratories, ensuring effective coordination, costs, and timelines follow-up.
  • Manage the implementation of new raw materials by defining the required tests, in alignment with the pharmacopeia.
  • Act as a Subject Matter Expert and participate in internal/external audits and HA's Inspections for method validation/transfer.

Requirements:
  • Master's or PhD in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experience, in a GMP environment.
  • Broad understanding of Cell-based assays, PCR, ELISA, Liquid Chromatography, Capillary Electrophoresis, Virology, Microbiology, and Microbiology.
  • Excellent skills in project management.
  • Fluent in French and English.


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