Senior Analytical Transfer
vor 4 Wochen
At Incyte, we are seeking an Expert in Analytical Method Validation to support the transfer and validation of analytical methods and all related activities throughout the product life cycle.
As a Subject Matter Expert (SME) in complex problem-solving, method improvement, and audit and inspection, you will manage comprehensive validation studies to assess the performance of analytical methods in accordance with regulatory guidelines and Good Manufacturing Practices.
Key responsibilities include:
- Managing validation studies to assess analytical method performance
- Writing, reviewing, and approving analytical transfer/validation/verification protocols, data, reports, test methods, and other related documentation
- Analyzing and interpreting results of validation studies and preparing detailed reports
- Acting as an analytical technical expert on multiple programs, collaborating with internal and external team members to move projects forward, and providing regular communication of analytical status to Program Managers
- Managing external laboratories, ensuring effective coordination, costs, and timelines follow-up, and providing guidance and support in method development, validation, verification, and transfers to external labs
- Defining required tests for new raw materials in alignment with the pharmacopeia and participating in internal/external audits and HA's inspections for method validation/transfer
- Performing regulatory and technical watch to ensure compliance with constantly evolving requirements
The ideal candidate will possess a 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.
Additional requirements include:
- Broad understanding of Cell-based assays, PCR, ELISA, Liquid Chromatography, Capillary Electrophoresis, Virology, Microbiology, and Microbiology
- Excellent skills in project management
- Excellent interpersonal, written, and communication skills
- Perfect knowledge of ICH guidelines on analytical methods, stability, comparability, and specification
- Knowledge of biologics CMC and IND/BLA submission is preferred
- Fluency in French and English
We respect your privacy and protect your personal data in accordance with our data protection practices.
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