Tech Transfer Lead
Über diese Stelle
We are seeking an experienced Tech Transfer Operations Lead to drive the successful transfer, industrialization, and launch of combination products, medical devices, and secondary packaging processes across a global manufacturing network.
Key Responsibilities
- Lead and support technical transfer activities for combination products, medical devices, and secondary packaging processes.
- Drive development\-to\-commercial manufacturing transfers across global production sites.
- Develop and execute technical transfer strategies in collaboration with cross\-functional stakeholders.
- Ensure alignment and standardization of transfer documentation, design transfer packages, and manufacturing processes.
- Support product launches by ensuring manufacturing readiness and supply availability.
- Manage lifecycle maintenance (LCM) activities and implementation of product or process changes.
- Act as technical lead or subject matter expert within cross\-functional project teams.
- Support assembly and packaging process design, scale\-up, validation, and commercialization activities.
- Partner closely with Development, MS\&T, Technical Operations, Quality, Regulatory Affairs, and Supply Chain teams.
- Support internal and external audits, inspections, and health authority interactions.
- Contribute to regulatory documentation and responses related to medical devices and combination products.
Your Profile
- Degree in Mechanical Engineering, Pharmaceutical Technology, Biomedical Engineering, Industrial Engineering, or related technical discipline.
- Advanced degree (MSc, PhD) preferred.
5\+ years of experience in:
- Pharmaceutical Manufacturing
- Manufacturing Science \& Technology (MS\&T)
- Technical Development
- Tech Transfer
- Medical Device or Combination Product Manufacturing
Demonstrated experience with:
- Technology Transfer
- Product Commercialization
- Manufacturing Transfers
- Product Launches
- Assembly and Packaging Processes
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