(Senior) CMC Expert* as (Associate) Director* Protein Development

  • Mainz
  • Work experience
  • Project Management, Product Management
  • 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.

(Senior) CMC Expert* as (Associate) Director* Protein Development

At BioNTech, you will be part of the project team leading external development and manufacturing of therapeutic proteins. Your main responsibilities are:
  • Represent development expertise (e.g. cell line development, upstream/downstream process development, analytical development) in assigned development projects
  • Create, review, and approve project documentation, including development reports, risk analysis, qualification/validation reports
  • Manage CMC timelines and budget; bring focus to risk management activities and implement processes to identify risks, maintain risk registry and proactively execute mitigation plans to help ensure effective program execution
  • Drive timely and data-driven decision making, and contribute to strategic discussions within CMC and with external partners
  • Drive continuous improvement of process and data quality, through streamlining and optimizing processes, automation, and digitalization

What you have to offer.

  • An Advanced Degree (Master of Science/PhD) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with several years of professional experience in an international, pharmaceutical environment
  • Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing)
  • Documented experience in CMC regulatory affairs would be a plus
  • In depth CMC development knowledge in either early or late stage projects with sound understanding of all stages of drug development
  • Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus
  • Leadership/management skills and assertiveness, capable of working in crossfunctional CMC teams
  • Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management
  • Experience defining and executing strategy is required

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 5426 (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