Technology Transfer Specialist – Multiple Locations
il y a 3 semaines
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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