Scientist (f/m/d)
Bavarian Nordic
- Thörishaus, Bern
- Unbefristet
- Vollzeit
- Perform all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes)
- Drive process implementation, process scale up and manufacturing for late-stage clinical trials as well as commercial product (link between Development as sending site and Production as receiving site)
- Equipment selection, dimensioning, and materials planning
- Create user requirements specification for equipment/ facilities
- GMP manufacturing support incl. troubleshooting (can also be person in plant for a period of time until process is established)
- SME for production problems in the area covered by the scientist and first point of contact
- Provide guidance on process transfer and support activities to junior members of the team
- Introduce ideas for process improvement and implement them in collaboration with the different teams
- MSc in biological sciences or related fields, PhD preferred
- Advanced knowledge of scale up and mass transfer, formulation, upstream processes (such as, cell biology, cell culture, bioreactor operation, etc.) and/ or downstream processes (such as ultrafiltration, harvest, chromatography, etc.)
- Intermediate knowledge of statistical data analysis and interpretation (JMP preferred)
- Strong experience in development / process definition of upstream processes by using human cell lines
- Experienced in aseptic technique and mammalian cell culture
- In depth knowledge of large scale manufacturing, current Good Manufacturing Practices and US/EU regulations
- Strong communication, technical writing, organizational and interpersonal skills; Strong computer skills (including Word, Excel, Outlook and PowerPoint)
- Critical thinking skills in problem solving and decision making; Attention to detail and high level of accuracy; The capacity to motivate and encourage others
- Excellent written (especially technical writing) and verbal communication skills in English. German is a plus but not mandatory
JobCloud