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Location/Division Specific Information

The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.

How will you make an impact?

You will be working on the upstream manufacturing process in a GMP (good manufacturing practices) environment to deliver quality lifesaving medication to patients around the world for serious and life threatening illnesses. Job functions include thawing and passaging of cells (propagation of mammalian cell culture), preparation of large scale bioreactors (50L – 2000L), daily analytical sampling, and processes / equipment troubleshooting as issues arise.

A successful candidate will be expected to carry out these functions and more while working effectively in a team and ensuring tasks are completed accurately and efficiency while adhering to strict GMP guidelines.

The upstream manufacturing team is a diverse group of individuals from all over the world with different backgrounds and experience. Each day, you will be working alongside your fellow team members to execute assigned tasks and complete all documentation associated with the work performed.

The upstream team works in shifts and a typical day will start at either 08:00 or 15:00 and end at either 16:30 or 11:30 and will include scheduled weekend work.

What will you do?

• Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions.

• Assist in all Department functions, such as maintaining clean room, supplies, equipment, logbooks and data in accordance with site SOPs and policies.

• Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.

• Critical evaluation of processes, including foresight and thinking ahead.

• Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.

• Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.

• Participate in shift exchanges, 1-1’s, meetings, as necessary to facilitate area needs based on changes, etc. (lean activities).

• Promote and monitor aseptic behaviors.

• Write and review operational SOP’s, work instruction and production batch records.

Knowledge and educational level

• Minimal MBO level (e.g. Biotechnology, Process technology).

• Good knowledge and working in cGMP environment necessary.

• Good knowledge of relevant process unit operations (e.g. fermentation, aseptic handling, filtration) is necessary.

• Understanding ‘why’ and not just the ‘how’ of processes and practices.

Required Level of Experiences

2 or 3 years of relevant experience in the bio (pharmaceutical) fields or combination of education and experience will is necessary.

Competences

• Flexibility

• Self-capable and dependent

• Eagerness to learn and can handle steep learning curves

• Excel at teamwork

• Works well under pressure in a fast-paced environment

• High level communication skills

• Fluent in English

• Planning and organization

• Effectively multi-task

• Able to work in an environment of change

• Able to work independently and as a part of a team

• Able to recognize problems developing, not just occurring