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Stellenbeschreibung
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Summary
The Specialist / Senior Specialist - Analytical Transfer & Validation supports the transfer and validation of analytical methods and all related activities throughout the product lifecycle, from Raw Materials to DS & DP testing. Acts as Subject Matter Expert (SME) for complex problem solving, method improvement, audits, and inspections. May coordinate activities of consultants in their area of responsibility.
Key Responsibilities
* Manage validation studies to assess analytical method performance, complying with regulatory guidelines and GMP.
* Write and review protocols, data, reports, test methods, and related documentation.
* Analyze validation results and prepare detailed reports.
* Serve as the analytical technical expert, collaborating with internal and external teams to advance projects. Coordinate with Program Management on expectations, timelines, and costs. Communicate analytical status regularly to Program Managers.
* Support budget planning, resource allocation, and tracking for activities under their responsibility.
* Manage external laboratories, ensuring effective coordination, costs, and timelines. Provide guidance on method development, validation, verification, and transfer.
* Implement new raw material testing in line with pharmacopeia requirements.
* Participate as SME in internal/external audits and health authority inspections related to method validation/transfer.
* Stay updated on regulatory and technical requirements to ensure compliance.
Education and Experience
1. Master's or PhD in biology, chemistry, biochemistry, chemical engineering, or related field with 5+ years of biotech industry experience in a GMP environment.
Knowledge, Skills, Abilities
2. Understanding of Cell-based assays, PCR, ELISA, Liquid Chromatography, Capillary Electrophoresis, Virology, Microbiology.
3. Strong project management skills.
4. Excellent interpersonal, written, and verbal communication skills.
5. Thorough knowledge of ICH guidelines on analytical methods, stability, comparability, and specifications.
6. Knowledge of biologics CMC and IND/BLA submissions is a plus.
7. Fluent in French and English.
Disclaimer : The above statements describe the general nature and level of work and are not exhaustive. Management may modify duties as needed.
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