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Spécialiste Tech Transfer

Il y a 2 mois

Colmar, Grand Est, France AKTEHOM Temps plein

Unlock Your Expertise in Tech Transfer

As a Tech Transfer Specialist, you will be responsible for guiding clients in structuring their approaches to Tech Transfer, ensuring compliance with regulatory authorities, and providing expertise on product development and transfer processes.

Key Responsibilities:

  • Pilot and manage projects related to Tech Transfer
  • Develop and implement strategies for Tech Transfer
  • Provide expertise on product development and transfer processes
  • Ensure regulatory compliance for client projects

Requirements:

  • 5+ years of experience in pharmaceutical development, Tech Transfer, and/or regulatory CMC
  • Significant expertise in Tech Transfer
  • Good knowledge of regulatory requirements (FDA, EMA, etc.) for dossier submissions (Partie CMC) for phases II and beyond
  • Mastery of quality and regulatory requirements, including GMP, ICH, and risk-based approaches to comparability and validation
  • Operational English language skills for client communication and report writing

About AKTEHOM:

AKTEHOM is a company that values expertise and collaboration. As a Tech Transfer Specialist, you will have the opportunity to work with a team of experts and contribute to the growth and development of the company.