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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