Associate Director* Bioanalytics

  • Mainz
  • Work experience
  • Quality Management, Quality Assurance
  • Research, development, teaching
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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.

Associate Director* Bioanalytics

As subject matter expert (SME) Bioanalytics you are responsible for delivering methods for PK, ADA and biomarker analytics required for all phases of clinical trials as well as cell based biopotency methods, each outsourced to external contract laboratories.

Your main responsibilities are:
  • Contribution to implement biomarker testing and biopotency assay strategy of multiple clinical trial projects
  • Selection of appropriate analytical technologies in collaboration with R&D teams and departments Translational Sciences, Clinical Pharmacology and CMC
  • Contribute to the global selection and management of contractors in terms of their technical appropriateness and compliance with the respective regulatory requirements
  • Responsibility for method transfer to or method development at external vendors (contract labs)
  • Responsibility for oversight of contract laboratories that perform feasibility studies, (further) development, and appropriate analytical validation of methods

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • a minimum of 5 years of experience in pharmaceutical or biotech industry
  • Solid experience in assay development and analytical validation of methods for PK, ADA and biomarker testing or cell based biopotency assays.
  • In-depth knowledge of GCP/GLP and/or GMP Quality Control as well as FDA and EMA requirements.
  • Ability to express complex issues in concise and clear language, very good English (written and spoken) and German (desired)
  • Ability to identify problems and find solutions, as well as attention to detail

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, 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 5689 (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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