Switzerland Recruitment Manager (Pharma & Med Device)
The Technology Transfer Specialist will be a key member of the Manufacturing Operations team, reporting to the Technology Transfer Lead.
This role is responsible for supporting New Product Introduction and contributing to the evolving site tech transfer strategy as a Change Champion within the organization and site.
Key Responsibilities:
* Develop and implement the tech transfer program.
* Collaborate with stakeholders to deliver GMP documents related to TT, such as risk assessments, change controls, batch records, sampling plans, and Bills of Material.
* Maintain and update information delivered from Development in digital tools like COMET SAP, MES, and DeltaV.
* Manage new program introduction schedules to ensure tasks are executed on schedule and right-first time.
* Represent Tech Transfer across various teams.
* Lead small projects with moderate resource requirements, risk, and/or complexity.
* Support process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Design and implement best practices in tech transfer.
* Assist in developing future breakthrough business solutions to reduce overall effort/risk, optimizing these for rapid product launch.
* Provide feedback and propose opportunities for optimization to current Tech Transfer processes.
* Create and maintain BOMs (Bill of materials), EBRs (Paper), gBMR (MES), and SOPs/WIs.
Candidate Requirements:
* Minimum 5 years work experience in the pharmaceutical or biotech industry.
* Familiarity with Unit Operations for mAb manufacturing.
* Basic project management knowledge.
* Competency in issuing and transcribing information into manufacturing documents like BOM, Batch Sheets, and DeltaV.
* Proficiency in automated/digital systems like DeltaV, MES, eVal, and SAP COMET.
* Working knowledge of GMP regulations.
* Understanding of New Product Introduction principles.
* Preference given to those who have managed a small project with a cross-functional group.