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Analytical Method Expert (Associate Director AS&T Lifecycle Management)

Mainz, Germany   |   full time   |   Job ID: 9405 

 

 

As Analytical Method Expert (Associate Director AS&T Lifecycle Management), you will be making a meaningful contribution to the ongoing product development and regulatory submission (BLA/MAA) of our RNA and Protein-based therapeutic pipeline as part of our Analytics, Science & Technology (AS&T) department.

In this role, you will be the main point of contact for specific methods within your area of expertise. You will ensure that the analytical methods comply with GMP standards and provide accurate, precise, and reliable results.

 

Your responsibilities:

  • Provide technical analytical expertise for late-stage and commercial projects in compliance with GMP standards and in accordance with relevant industry guidelines           
  • Responsible for method validation and transfer strategies as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations) 
  • Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners           
  • Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products            
  • Act as analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions      

 

What you have to offer:

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:

  • An advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
  • Industry experience (5+ years) in CMC development/commercial
  • Background in organic chemistry (synthesis of small molecules and/or analytical chemistry) and/or Biologics product development
  • In-depth knowledge of analytical techniques in one of the following fields, with hands-on experience in assay development and validation, as well as data analysis and statistical evaluation:
    • HPLC, GC, mass spectrometry, NMR, and IR techniques for the analysis of small molecules
    • Chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques for the analysis of mAbs/ADCs
    • Cell-based and immunoassays, as well as molecular biology and physicochemical techniques for determining potency and biological activity, which reflect the mechanism of action of a product
  • Expertise in the definition of analytical control strategies, method validation concepts, and setting specifications for biologics and/or small molecules
  • Experience in working in intercultural, cross-functional teams
  • Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
  • Highly motivated and willingness to work in a fast-paced and fast-evolving environment

 

 

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 9405 (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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