Process Engineer* Drug Substances (DS)

  • 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.

Process Engineer* Drug Substances (DS)

As Process Engineer* Drug Substances (DS), you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will be responsible for technology transfers, improvement and monitoring of manufacturing processes, and leading technical projects acting as decision authority for operational technical projects. Your main responsibilities are:
  • Leading technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing and ensure on-time execution for manufacturing processes of his discipling (e.g. DS), incl. GMP documentation for regulatory approval  
  • Designing and conducting process qualification and validation and driving continuous improvement of process robustness
  • Monitoring for BioNTech of product and process parameters
  • Leading end-to-end change control management (e.g., working with Technology Development, Regulatory, QA)
  • Investigating and problem solving upcoming process issues
  • Supporting new process design and risk assessment for new initiatives
  • Providing support on technical processes to other teams, share Lessons Learnt

What you have to offer.

  • University degree in (Life) Science or Engineering
  • Practical experience in the life science industry (ideally a biotech or pharmaceutical company)
  • Several years of practical experience and expertise in Drug Substances (DS) process engineering
  • Experience with technology transfer of Biotech products, methods for technology transfer comparability assessments, and process performance qualification 
  • Profound knowledge of EU / US GMP guidelines and regulatory standards
  • Strategic and analytical thinking skills to identify risks and prepare balanced decisions
  • Excellent process management skills, Lean and Six Sigma qualifications preferred 
  • Creativity and the ability to develop a flexible approach to changing conditions, distinct analytical and conceptual competencies
  • High team spirit and excellent collaborating skills
  • Good communication skills, fluency in German and English

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 Mainz and simply send us your application documents using our online form.

If you have any further questions, Sarah Huber will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).

*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!

BioNTech - As unique as you

https://biontech.de