Description
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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