Associate Director* AS&T Method Owner - Microbiology / Phys&Chem / RNA&Lipids

  • Mainz
  • Work experience
  • Production, manufacturing
  • Quality Management, Quality Assurance
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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* AS&T Method Owner - Microbiology / Phys&Chem / RNA&Lipids

As AS&T Method Owner for Microbiology, Phys&Chem or RNA&Lipids, you will be making a meaningful contribution to the ongoing development of our RNA production processes as part of our Analytics, Science & Technology (AS&T) department. In this role, you will be responsible for the development and supervision of the life cycle management for either a) microbiological, b) physical/chemical, or c) RNA and Lipid related analytical methods in a contract manufacturing organization (CMO) and contract laboratory network. 

Your main responsibilities will be:
  • Owning the analytical methods within AS&T working groups and project teams of a broader scope (e.g., tech transfers), i.e. implementation, validation, trending, and continuous improvement
  • Managing AS&T programs and projects related to the methods, as well as the life cycle of a set of analytical methods
  • Ensuring that stability programs related to analytical methods are conducted with respect to Health Authorities' requirements, and owning the method part for the stability process
  • Identifying, qualifying and managing usage of respective methods of internal and contracted Laboratories to assure compliance with current Good Manufacturing Practice (cGMP)
  • Contributing to the setup and maintenance of processes for analytical data handling at CMOs and external labs
  • Representing physical and chemical Quality Control (QC) in internal and external cross-disciplinary teams as responsible expert for method life cycle and analytical transfers
  • Providing physical and chemical QC input for process validation and compilation of Module 3 content for new development projects

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology)
  • Several years of work experience in a GMP laboratory role as well as within QC (method development, method validation, stability testing), incl. experience in a Biotech or pharmaceutical QC laboratory
  • Experience in analytical method development and optimization is a plus
  • Deep expertise of FF QC laboratory environment, and equipment associated with testing biopharmaceutical products
  • Knowledge of the newest analytical methods in biotechnology or pharma
  • Proven track record with regulatory inspections (EMA/FDA or other)
  • Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, Good Manufacturing Practices, as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia)
  • Conscientiousness and detail-orientation
  • Creativity and the ability to develop a flexible approach to changing conditions
  • Great communication skills, incl. technical writing, 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 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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