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CMC Material Expert

Mainz, Germany   |   full time   |   Job ID: 9211 

 

 

As a key member of our global CMC team, the CMC Material Expert plays a crucial role in overseeing phase-appropriate requirements concerning raw materials and excipients. This includes authoring and maintaining gap assessments for specific products, as well as managing relevant Quality by Design (QbD) documents such as Critical Material Attributes (CMA) and Critical Quality Attributes (CQA) templates. As an experienced professional, you will train, guide, and support members of project-specific CMC teams.

Please note: This position is a temporary parental leave replacement for 18 months and cannot be offered on a permanent basis.

 

Your main responsibilities are.

 

  • Oversee the development and maintenance of material-related QbD documents, including CMA and CQA templates.
  • Collaborate effectively with internal and external teams to ensure compliance with material requirements in a phase-appropriate manner throughout all clinical phases leading up to BLA and MAA. submission.
  • Support CMC teams to ensure fulfillment of all material requirements (phase-appropriate) with main focus on individualized RNA therapeutics.
  • Drive continuous improvement of processes for assessing and procuring of raw materials and excipients.

 

What you have to offer.

 

  • A degree in a scientific or engineering field; advanced degree preferred.
  • Minimum of 5 years of experience in the pharmaceutical or biotech industry, with at least 3 years specializing in materials.
  • Profound knowledge of GMP regulations and biopharmaceutical manufacturing requirements, particularly related to materials.
  • Expertise in QbD approaches with an emphasis on materials.
  • Exceptional communication and interpersonal skills for fostering strong relationships with both internal and external stakeholders.
  • Ability to work independently and prioritize tasks in a fast-paced, dynamic environment.
  • Strong intra-cultural expertise and fluency in English, both written and verbally.

 

 

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 9211 (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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At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.  

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.  

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. 

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!  

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