Product Steward* iNest (Individualized Neoantigen Specific Immunotherapy)

  • BioNTech Careers
  • Mainz
  • Work experience
  • Production, manufacturing
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Product Steward* iNest (Individualized Neoantigen Specific Immunotherapy)

In this role, you will be responsible for technology transfers, improvement and monitoring of manufacturing processes and act as part of the MS&T team as decision authority for operational technical projects. Your main responsibilities are:
  • Act as SME / technical lead during project phase for the respective area and ensure smooth transition from project phase to commercial manufacturing
  • Lead technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing. Ensure on-time execution for manufacturing processes of his discipling (e.g. DS), incl. GMP documentation for regulatory approval
  • Design and conduct process qualification and validation and drive continuous improvement of process robustness. 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 as well as support new process design and risk assessment for new initiatives
  • Provide support on technical processes to other teams and share Lessons Learnt

What you have to offer.

  • Degree in life sciences, process engineering or similar
  • Sound professional experience in the life science industry (ideally a biotech or pharmaceutical company) in the field of manufacturing and/or quality
  • In-depth knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practices (GMP)
  • Independent working style with a lot of initiative, solution-oriented and analytical thinking
  • High team spirit, excellent interpersonal skills and ability to work in a fast paced environment
  • Strong communication skills and fluency in English and German

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location  and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 5144 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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https://biontech.de