Position Summary

The role is responsible for being the main technical support person for manufacturing processes in the area of Virus like Particle production/Mammalian Cell expression. The person has experience with GMP manufacturing processes and will support technology transfers from Development sites to receiving commercial sites. The Scientist is a subject matter expert for various aspects in process understanding, design and analytics and is expected to question and solve on tasks when clarification or greater technical expertise is required and may provide immediate supervision or assign tasks to a unit or group of employees. The role is supposed to serve as a link between Development (as sending unit) and Validation/ Production (as receiving unit). 

What you can expect

• 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

Your skills and qualifications

• 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

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile MSAT team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills. Additionally, we offer an extensive benefits package and a competitive compensation package.

Are you interested in joining our mission? We look forward to receiving your application!