Analytical Transfer and Validation Senior Specialist
vor 4 Wochen
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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