Associate Director* As&t Cmo Oversight

Mainz, Germany

Job Description

Senior, very experienced
Quality Management, Quality Assurance

Become a member of the BioNTech Family!

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.

We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.

Associate Director* AS&T CMO Oversight

As Quality Control External Manufacturing, you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will support us on our mission by increasing analytical/microbial testing robustness, efficiency and compliance as the main contact of Contract Manufacturing Organizations (CMOs).

Your main responsibilities will be:
  • Supporting CMOs during whole onboarding process regarding analytical/microbial test transfer and test set up, stability studies and sampling plans
  • Conducting analytical investigations (OOS, complaints, deviations) and problem solving activities during technology transfer and routine production in internal and external laboratories and at CMOs in case of analytical/microbial test deviations
  • Facilitating analytical technology transfer projects, writing of transfer documents like analytical GAP analysis, transfer strategy, method transfer plans and reports
  • Overseeing the creation/revision and approval of AS&T-owned Standard Operating Procedures (SOPs), work instructions, technical documentation package and other supporting documents
  • Supporting the evaluation and implementation of new technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders
  • Providing support for troubleshooting and continuous improvement in the laboratory

What you have to offer.

a) University degree in pharmaceutical or Science/Chemistry (or equivalent),
plus practical experience on a manufacturing site or with external partners (CMOs), as well as with managing CMO quality and analytical method transfer

b) Advanced degree in life science or healthcare (or equivalent), plus practical experience of quality compliance governance, and good understanding of quality compliance management obligations (incl. statutory obligations), requirements, requirements and dynamics
  • Several years of working experience and good knowledge of the QA/QC release process
  • Profound knowledge of relevant US and EU, EMA, FDA regulatory standards as well as Good Manufacturing Practice; especially good understanding of quality compliance management obligations (incl. statutory obligations), requirements, requirements and dynamics
  • Creativity and the ability to develop a flexible approach to changing conditions
  • High conscientiousness and detail-orientation
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills

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, Johanna Diehl 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!

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Job Detail

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    Mainz, Germany
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