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Tech Transfer Specialist
Il y a 2 mois
Unlock Your Expertise in Tech Transfer
As a Tech Transfer Specialist, you will play a key role in helping clients structure their approaches to technology transfer, comparability, and guiding them on the expectations of health authorities.
Your Key Responsibilities:
- Pilot and accompany AKTEHOM teams to assist clients on missions:
- Project management of technology transfer projects
- Strategy and implementation of transfers
- Expertise on the development process of products/ processes or technology transfer to achieve key milestones
- Ensuring regulatory compliance of client projects in accordance with health authority requirements, from development to registration, or in variation contexts
Key Skills and Qualifications:
- 5+ years of experience in pharmaceutical development, technology transfer, and/or regulatory CMC
- Significant expertise in technology transfer
- Good knowledge of health authority expectations (FDA, EMA,...) for dossier submissions (Partie CMC) for phases II and beyond
- Mastery of quality and regulatory requirements, including GMP, ICH, and approaches to comparability and validation based on risk management
- Operational English level for animation of meetings and writing of deliverables for non-French speaking clients
What We Offer:
- A dynamic and challenging role with opportunities for growth and development
- A collaborative and supportive team environment
- The chance to work with a variety of clients and projects
Join Our Team:
As a Tech Transfer Specialist, you will be responsible for the technical and human success of each client project you participate in. You will ensure the development of client relationships and the development of AKTEHOM competencies. You will also provide technical, scientific, methodological, and regulatory support to clients and the AKTEHOM team.
Additional Opportunities:
- Progression to other areas related to AKTEHOM's areas of expertise (Product/Process Mastery, Contamination Mastery, Analytics, Quality Systems, Compliance...)
Location:
Post based in Paris, Lille, Lyon, or Colmar.
