Analytical Method Expert (Associate Director AS&T Lifecycle Management

Mainz, Germany; Gaithersburg, US full time Job ID: 9405

This position can be filled either in Mainz (Germany) or Gaithersburg (US).

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 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 ( (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.

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