Everyone can achieve great things at BioNTech! We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. 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!

At BioNTech Innovative Manufacturing Services, we have made our goal to revolutionize the treatment of diseases with cell and gene therapy. Join us in this mission in Idar-Oberstein!

Biologist* as Head of Department Qualification / Validation - Quality Assurance

Here, you’ll achieve greatness.

At BioNTech IMFS, you accomplish an important contribution to the manufacturing of cellular medical products and gene therapeutics for the use in clinical studies. Your duties in detail are:
  • Management of the Department Qualification / Validation with 3 employees
  • Creation, review and release of GMP-relevant regulations, documents and contracts in relation with Qualification / Validation
  • Creation of the Validation Master Plan
  • Supervision of Qualification and Validation measures in the departments of production, quality control and CS (QA-Oversight)
  • Creation of overall SOPs and protocols for the conduction of qualification and validation measures
  • Processing of deviations, changes and CAPA-measures
  • Training of the employees in qualification and validation relevant topics

What you have to offer.

  • Completed scientific university degree or similar qualification
  • Profound knowledge of the national and international GMP regulations for clinical test samples, ATMPs and authorised medicines
  • At least 5 years practical experiences in the field of quality assurance especially in the field of audits, contracts, supplier qualification and authorities communication
  • Extensive practical experiences in the field of Qualification (RA, DQ, IQ, OQ, PQ) and Validation under GMP
  • Reliability, team spirit and organizational talent
  • Safe handling of MS Office programs and very good command of German and English spoken and written

Benefits for you.

...and much more.
 

Have we kindled your pioneering spirit?

Then apply now for our location Idar-Oberstein and look forward to becoming part of a highly qualified, motivated, and collegial team, in which you can expect exciting tasks and new career prospects. Simply send us your application documents using our online form.

If you have any further questions, please contact Sarah Kiekbach +49 (0) 6781 9855-211. 

*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.
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