Axepta SA Senior Analytical Transfer Expert Envoyer

We are looking for a Sr Analytical Transfer Expert for one of our prestigious client, within the QC Operations department of their northern Vaud site.

Responsibilities :

• Lead comprehensive validation studies to evaluate the performance of analytical methods, ensuring alignment with regulatory guidelines and Good Manufacturing Practices (GMP).
• Develop, review, and approve analytical transfer, validation, and verification protocols, data, reports, test methods, and related documentation.
• Interpret and analyze validation study results, preparing detailed and comprehensive reports.
• 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. Responsible for planning, timelines, and cost reporting. Regularly update Program Managers on analytical progress.
• Provide expertise in analytical methods development for product development programs.
• Contribute to establishing a platform laboratory to ensure the rapid implementation of new methods in product development programs.
• Assist in budget definition and tracking, and identify resource needs for activities under your responsibility.
• Coordinate with external laboratories, if applicable, to ensure effective collaboration, cost management, and timeline adherence. Offer guidance and support in method development, validation, verification, and transfers to external labs.
• Oversee the implementation of new raw materials by defining necessary tests in alignment with pharmacopeial standards.
• Act as a Subject Matter Expert (SME) and participate in internal/external audits and Health Authority (HA) inspections related to method validation/transfer.
• Conduct regulatory and technical monitoring to ensure compliance with evolving industry requirements.
  
  

Profil :

• Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment
• Ideally between 8-10 years' experience in project management, analytical transfer and analytical validation
• Strong understanding of Elisa, Virology, Microbiology, PCR.

• Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification

• Fluent in French and English