Scientist* Early Stage Formulation Process Development (CMC)

scheme imagescheme imagescheme image

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.

Scientist* Early Stage Formulation Process Development (CMC)

As part of the CMC Formulation Process Development team, you will contribute to the design and execution of CMC studies to contribute to technical reports for regulatory filing. Your main responsibilities are:
  • Process engineering and technical oversight for the team; planning, execution and reporting (including official reports to external partners or authorities) of numerous types of CMC laboratory experimental studies (e.g. in use stability, process compatibility and bridging etc.)
  • Acting as the SME for processes introduced into BioNTech
  • Contributing to technical documentation for regulatory filling
  • Coordination and management (incl. self-responsible contacting manufacturers, CMOs, CROs etc.) of activities related to the material logistics, supply and inventory management for various CMC experiments and scenarios
  • Responsibility for instruments, laboratory management and supervision of Student Assistants and Research Associates
  • Independent and autonomous data processing, evaluation, documentation of experiments, and writing of reports (internal & official reports)
  • liaising with various departments and external partners to devise experimental plans and strategies to serve the CMC sections of Regulatory documents

What you have to offer.

  • PhD in a relevant scientific area
  • Experience in process design for formulation development gained in a pharmaceutical or biotech environment
  • Knowledge of the regulatory documentation process for drug development
  • Hands on experience with regulatory fillings is preferable
  • A multi-disciplinary background gained through working in analytical and pre-clinical development departments is preferable
  • Strong planning expertise and a quality oriented approach to report writing
  • Coordination and management of internal and external partners
  • Some experience in laboratory management and supervision of Student Assistants and Research Associates
  • Fluency in English both written and spoken is a requirement

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, Reece Freeman will be happy to answer them on + 49 (0) 6131-9084-1211 (monday-friday, from 12 noon).

*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.

BioNTech - As unique as you

https://biontech.de