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* GMP Compliance – 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 GMP Compliance with 10 employees
- Further Development of the pharmaceutical quality system
- Creation of systemically and cross-functional SOPs
- Creation, examination and authorization of GxP-relevant regulations, documents and contracts
- Conduction of internal and external audits plus certification of suppliers and service providers
- Organization and conduction of client audits and authority inspections
- Care and resubmission of approval documents and comparable authority permissions
- Supervision of stability studies and durabilities of the products
- Processing of deviations, changes and CAPA-measures
- Creation of quarterly reports and annual reports
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.
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.
BioNTech - As unique as you