(Senior) CMC Expert* as (Associate) Director* Materials

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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.

(Senior) CMC Expert* as (Associate) Director* Materials

You will be responsible for leading and coordinating all technical and regulatory aspects of raw materials and excipients for development projects within the BioNTech pipeline. Your main responsibilities are:
  • Collaborate with research and development teams in definition of raw materials and excipients for the development programs
  • Within the procurement process, lead the technical evaluation of potential sources of material, provide specifications for materials and perform quality assessment of materials
  • For second supplier define processes to ensure technical equivalence of materials and regulatory acceptance of all suppliers
  • Drive continuous improvement of processes for assessment and procurement of raw materials and excipients

What you have to offer.

  • An Advanced Degree (Master of Science/PhD) in Pharmacology, Chemistry, Biopharmaceuticals, or Biochemistry with several years of professional experience in an international, pharmaceutical environment
  • Sound knowledge of different scientific/technical CMC development functions including GMP requirements (eg pharmaceutical and/or analytical development, manufacturing)
  • Experience in CMC regulatory affairs would be a plus
  • Hands on experience working in a quality function with good understanding of all stages of drug development
  • Experience with regulatory filings (IND/IMPD, BLA/MAA) is considered a plus
  • Management skills and assertiveness
  • Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management

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 5418 (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!

BioNTech - As unique as you

https://biontech.de