For our client, a pharmaceutical company based in canton Lucerne, we are looking for a Technology Transfer Specialist.
The successful candidate will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. You will be responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
The Technology Transfer Specialist role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.
General Information:
* Start Date: ASAP/March 2025
* Planned duration: until 31.07.2026
* Extension: possible (to be discussed)
* Home office: possible up to 2 days per week
Responsibilities and activities can be tailored to successful candidate availability and career plan and would primarily entail, but are not limited to:
* Support of developing tech transfer program.
* Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
* Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV.
* Manage new program introduction schedule to ensure tasks are executed on schedule and right-first time.
* Contribute/support in various teams as Tech Transfer representative.
* Manages small projects with moderate resource requirements, risk and/or complexity.
* Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Supports design and implementation of best practices in tech transfer.
* Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to “one-click” tech transfer.
* Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.
* Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s.
* Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams.
* Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives.
* Support to aggregate process related knowledge and centralize for knowledge management.
* Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
* Ensure the highest Quality, Compliance and Safety standards.
Must haves:
* A degree qualification in a relevant field (Science/Technical).
* Minimum of 3 years of work experience in the pharmaceutical or biotech industry.
* Fluent English (oral and written).
* Familiarity with Unit Operations for mAb manufacturing.
* Project management basic knowledge.
* Competent in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets and DeltaV.
* Competency in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMET.
* Has managed a small project with a cross-functional group.
* Working knowledge of cGMP regulations.
* Understanding of the general principles of New Product Introduction (Tech Transfer).
Preferred Experience and Skills:
* Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
* Competent in analyzing complex situations and showing practical problem-solving capabilities.
* Familiarity with risk assessment processes.
* Familiarity with the use of Automation systems in a manufacturing Process.
* Ability to work effectively as part of a team and independently.
Seniority level
Associate
Employment type
Contract
Job function
Engineering and Science
Industries
Staffing and Recruiting
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