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 Method Owner Physics and Chemistry
As Director Analytical Method Physics and Chemistry, 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 physical/chemical analytical methods (implementation, validation, trending, continuous improvement) 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)
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
... 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!
BioNTech - As unique as you
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