Senior Analytical Transfer Specialist
vor 13 Stunden
We are seeking a highly skilled Senior Analytical Transfer Expert to join our team at Axepta SA. As a key member of our QC Operations department, you will play a critical role in ensuring the quality and integrity of our analytical methods.
Key Responsibilities:- Method Validation and Transfer: Lead comprehensive validation studies to evaluate the performance of analytical methods, ensuring alignment with regulatory guidelines and Good Manufacturing Practices (GMP).
- Protocol Development and Review: Develop, review, and approve analytical transfer, validation, and verification protocols, data, reports, test methods, and related documentation.
- Results Interpretation and Reporting: Interpret and analyze validation study results, preparing detailed and comprehensive reports.
- Technical Expertise: Serve as the analytical technical expert on multiple programs, collaborating with internal and external team members to advance projects. Work closely with Program Management to establish clear expectations and achieve successful outcomes.
- Method Development: Provide expertise in analytical methods development for product development programs.
- Platform Laboratory Establishment: Contribute to establishing a platform laboratory to ensure the rapid implementation of new methods in product development programs.
- Resource Management: Assist in budget definition and tracking, and identify resource needs for activities under your responsibility.
- Collaboration and Coordination: Coordinate with external laboratories, if applicable, to ensure effective collaboration, cost management, and timeline adherence.
- Regulatory Compliance: Oversee the implementation of new raw materials by defining necessary tests in alignment with pharmacopeial standards.
- Subject Matter Expertise: Act as a Subject Matter Expert (SME) and participate in internal/external audits and Health Authority (HA) inspections related to method validation/transfer.
- Regulatory Monitoring: Conduct regulatory and technical monitoring to ensure compliance with evolving industry requirements.
- Scientific Background: Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment.
- Experience: Ideally between 8-10 years' experience in project management, analytical transfer and analytical validation.
- Technical Skills: Strong understanding of Elisa, Virology, Microbiology, PCR.
- Language Skills: Fluent in French and English.
Company: Axepta SA
Job Type: Full-time
Industry: Pharmaceutical
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