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Director Protein & ADC Analytics

Mainz, Germany   |   full time   |   Job ID: 9843 

 

 

The Director Protein & ADC Analytics is part of the CMC project team leading internal and external development and manufacturing activities of protein-based therapeutics and antibody drug conjugates (ADCs) with a special technical focus on linker-payload analytics. You will provide scientific and technical input primarily to small molecule analytical aspects within CMC development programs and is responsible for review and approval of development and release/stability documentation according to regulatory expectations. Also the Director Protein & ADC Analytics provides strategic and scientific input to the assigned development programs and is responsible for establishment and execution of the analytical development and control strategy. In addition, the Director Protein & ADC Analytics serves as direct contact for CDMO and external collaboration partners related to the area of expertise.


Your main responsibilities are.

 

  • Providing technical analytical expertise with focus on linker-payload for early and late-stage development programs in compliance with GMP standards and in accordance with relevant industry guidelines
  • Participating in strategic and technical discussions within projects in analytical expert sub-teams as well as cross-functionally with CMC team members and external partners
  • Acting 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
  • Ensuring analytical method development, validation and transfer in alignment with overall project strategy & requirements
  • Conducting analytical investigations and problem-solving activities during technology transfer and routine production
  • Overseeing the creation/revision and approval of work instructions, transfer/validation documentation, and other supporting documents
  • Supporting the evaluation and implementation of new technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders

 


What you have to offer.

 

  • Master’s degree or preferably Ph.D. in Analytical Chemistry or a related field, with at least 10 years of experience in an international, highly regulated environment
  • Strong expertise in small molecule and ADC drug linkers analytical chemistry, including techniques such as HPLC, GC, mass spectrometry, NMR, and IR, with experience in assay development, validation, and statistical data analysis
  • Proven experience in authoring CTD module 3 drug substance sections for regulatory submissions and filings
  • In-depth knowledge of analytical control strategies, method validation, stability/degradation study design, and specification setting
  • Solid understanding of standard quality processes (e.g., OOX, deviations, change controls, CAPAs)
  • Experience working in intercultural and cross-functional teams, with excellent project management skills
  • Strong communication and negotiation skills in English (German is a plus), with the ability to convey complex technical matters concisely to diverse stakeholders

 

 

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 9843 (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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