Specialist / Senior Specialist Analytical Transfer & Validation, Yverdon-les-Bains
vor 1 Tag
Client: Incyte
Location: Yverdon-les-Bains
Job Category: Other
Job Reference: af3f0be1f2bc
Job Views: 8
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:Summary:
The Specialist / Senior Specialist - Analytical Transfer & Validation supports the transfer and the validation of analytical method and all analytical activities related to the product life cycle, from Raw Materials to DS & DP testing; acts as Subject Matter Expert (SME) for complex problem solving, method improvement, audit and inspection. May be required to coordinate the activities of consultants in his/her area of responsibility.
Key Responsibilities:- Manage comprehensive validation studies to assess the performance of analytical methods, in accordance with regulatory guidelines and Good Manufacturing Practices.
- Write, review analytical transfer/validation/verification protocols, data, reports, test methods and other related documentation.
- Analyze and interpret results of validation studies and prepare detailed reports.
- Act as the analytical technical expert on multiple programs, collaborate with internal and external team members to move projects forward. Collaborate with Program Management to ensure clear expectations and successful results. Responsible for planning, timelines, and cost reporting. Provide regular communication of analytical status to Program Managers.
- Support budget definition and tracking, and define resource needs for execution of activities under his/her responsibilities.
- Manage external laboratories, ensuring effective coordination, cost and timeline follow-up. Set guidance and provide support in method development, validation, verification, and transfers to the external labs.
- Manage the implementation of new raw materials by defining the required tests, in alignment with the pharmacopeia.
- Act as SME and participate in internal/external audits and HA’s Inspections for method validation/transfer.
- Perform regulatory and technical watch to ensure compliance with constantly evolving 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.
- 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.
- Fluent in French and English.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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Yverdon-les-Bains, Schweiz Incyte VollzeitAperçu Summary The Specialist / Senior Specialist - Analytical Transfer & Validation supports the transfer and the validation of analytical method and all analytical activities related to the product life cycle, from Raw Materials to DS & DP testing; acts as Subject Matter Expert (SME) for complex problem solving, method improvement, audit and...
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