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Specialist (m/w/d) External QC Network

Mainz, Germany   |   full time   |   Job ID: 9793 

 

 

Your responsibilities are:  

 

•    Act as a QC point of contact in multidisciplinary project teams to support the implementation of QC project strategies for various protein projects (ADC, mAb, bispecific antibodies) 

•    Oversee QC-activities at CDMOs and ensure delivery of QC-associated work packages (data evaluation, deviation/OOS-investigations, CoA generation) in time and quality 

•    Provide technical support in monitoring QC activities at external CDMOs, particularly regarding project tasks and process implementation 

•    Contribute to the preparation and approval of QC-related GMP documents, test procedures, reports, changes, deviations, and OOS  

•    Perform raw date checks and evaluation of stability data 

•    Assist in managing the QC value chain (e.g., release and stability testing) in collaboration with CDMOs and contract laboratories, covering intermediates to finished products 

 

What you have to offer: 

•    University degree in a scientific/life-science-related field (M.Sc. would be a plus)  

•    Proven experience in Quality Control within the biopharmaceutical or biotechnology industry, ideally with exposure to protein projects such as ADCs, mABs, or bispecific antibodies  

•    Strong knowledge of QC processes, including data evaluation, deviation/OOS investigations, CoA generation, and GMP documentation (e.g., test procedures, reports, raw data checks, and stability testing/evaluation) 

•    Ideally experience in working with CDMOs or contract laboratories, including oversight of QC activities and ensuring compliance with timelines and quality standards 

•    Analytical background with proteins and antibodies is a plus  

•    Ability to manage multiple QC-related tasks simultaneously 

•    Fluent English (both oral and written)

 

 

Your Benefits:

 

It's our priority to support you:

  • Your flexibility: flexible hours | vacation account  
  • Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
  • Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
  • Your health and lifestyle: Company bike
  • Your mobility: Job ticket | Deutschlandticket 
  • Your life phases: Employer-funded pension | Childcare 

 

 

Apply now - We look forward to your application!

 

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

 

Job ID 9793 (please always specify if you have any questions)   

 

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

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Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. 

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