Analytical Method Expert; Associate Director AS&T Lifecycle Management

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Mainz, Germany;
Gaithersburg, US | full time | Job

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

It's our priority to support you:

• Your flexibility: flexible hours |vacation account
• 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 life phases:
  Employer-funded pension | Childcare

Apply now - We look forward to your application!

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

Job (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 ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.

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