Pharmacist, Chemist as CMC mAB Specialist - Regulatory Affairs, Clinical Development*

Everyone achieves greatness at BioNTech! That’s because, as the largest privately held biotechnology company in Europe, we are working on revolutionary approaches in the fight against cancer and other diseases. Over 1000 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!

CMC mAB Specialist* Global Regulatory Affairs

Here, you’ll achieve greatness.

At BioNTech, you will lead manufacturing of monoclonal antibodies (mAB) for BioNTech´s clinical trials. You will make strategic decisions that ensure product quality and supply of therapeutics. Furthermore, you will compile the CMC content for the regulatory documents. In your role, you will act globally and work cross-functionally.
Your duties in detail:
  • Support in definition and conduct of CMC development strategy of all BioNTech´s mAB products from FIH to launch
  • Planning and supervision of manufacturing of mAB for clinical trials inclusive main point of contact for CMOs and CTOs
  • Compilation of CMC content for regulatory documents of mAB in clinical development phases incl. active role in consultations of agencies
  • Planning and coordination of process validation and compilation of BLA and MAA
  • Support in contracting of CMOs, CTOs and quality assurance measures
  • Participation in internal and external cross-disciplinary teams as responsible person for mAB CMC aspects

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • 5 years professional working experience in manufacturing of mAB in the development (preferable both USP and DSP)
  • 2 years professional working experience in CMC Regulatory Affairs in the development of biologics
  • Knowledge of drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development, manufacturing and commercialization
  • Result-and goal-oriented
  • Excellent communication skills in English, preferably also in German

Benefits for you.

  • Jobticket
  • Child Care
  • Company Bike
  • Fitness
  • Pension
  • Relocation
...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, Friederike Mangelsen 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, 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

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Über BioNTech SE

Bei BioNTech leistet jeder Großes! Denn als eines der am schnellsten wachsenden Biotechnologie-Unternehmen Europas arbeiten wir an revolutionären Ansätzen im Kampf gegen Krebs und andere Krankheiten. Über 1000 Pioniere, die mit viel Herzblut neue Wege beschreiten, schaffen immer wieder aufsehenerregende Erfolge und vielversprechende Durchbrüche – und sorgen dafür, dass Menschen rund um die Welt...
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