Technology Transfer Specialist – Multiple Locations

il y a 3 semaines


Lille, Hauts-de-France AKTEHOM Temps plein

Position Overview: Are you a seasoned expert in Technology Transfer eager to guide clients in optimizing their transfer strategies while navigating health authority expectations?

Role Responsibilities: As a Technology Transfer Specialist, you will collaborate with AKTEHOM teams to support clients in:

  • Managing technology transfer projects effectively
  • Formulating and executing transfer strategies
  • Delivering specialized knowledge in product/process development or technology transfer to meet critical milestones
  • Ensuring adherence to regulatory standards for client projects, aligning with health authority requirements from initial development through to registration or variations.

Client Engagement: You will play a pivotal role in ensuring both the technical and interpersonal success of each client project, nurturing client relationships and enhancing AKTEHOM's expertise.

Support and Collaboration: You will provide comprehensive technical, scientific, methodological, and regulatory guidance to clients and the AKTEHOM team.

Additional Opportunities: You will also have the chance to engage in other areas of AKTEHOM's expertise, including Product/Process Control, Contamination Control, Analytical Services, Quality Systems, and Compliance.

Qualifications: Candidates should possess a background in engineering or pharmacy, with a minimum of 5 years of experience in pharmaceutical development, technology transfer, and/or CMC regulatory affairs.

Desired Skills: Your previous experience should have equipped you with:

  • Extensive knowledge in technology transfer
  • Familiarity with health authority requirements (FDA, EMA, etc.) for dossier submissions (CMC Section) for Phase II and beyond
  • Expertise in quality and regulatory standards, particularly GMP guidelines, ICH protocols, and risk-based comparability and validation strategies
  • Operational proficiency in English to facilitate meetings and create deliverables for international clients.

Client-Centric Approach: A strong commitment to customer service and a multidisciplinary perspective will be essential in establishing trust with clients and your team.



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