A large and well experienced bio-pharmaceutical company with a great commitment to improve people s health through the developing of new immunotherapies merging research with operational skills. Addressing the challenges of our new era, we developed the COVID-19 mRNA vaccine thanks to the best scientific team. Our key to success: stay united, innovative and passionate. Join us in our great commitment with the world!
Responsibilities
*Responsible for technology transfers, related to the development of RNA production processes. Lead technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing.
*MS&T team lead for technical projects acting as decision authority for operational technical projects. Support new process design and risk assessment for upcoming projects.
*Handling GMP documentation.
*Elaborate and put in practice process qualification and validation as long as improvements overall.
*Monitoring for BNT of product/process parameters.
*Lead end-to-end change control management (e.g. working with Tech Development, Regulatory, QA)
*Investigate and problem solve upcoming process issues. Provide interesting knowledge and support on technical processes to other teams.
Requirements
*University degree in (Life) Science or Engineering
*3 to 5 years of experience in the life science industry (ideally in a bio-tech or pharmaceutical company)
*Experience with:
*technology transfer of Bio-tech products, methods for technology transfer comparability assessments, and process performance qualification.
*and expertise in Fill & Finish process engineering.
*Solid knowledge of EU / US GMP guidelines and regulatory standards
*Lean and Six Sigma qualifications preferred.
*Fluent German and English.
*Management and team leading skills.
Benefits For You.
*Company Pension Scheme
*Childcare
*Jobticket
*Company Bike
*Leave Account
*Fitness Courses
*Mobile Office
*Special Vacation
