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BioNTech IMFS

Associate Director Analytical Chemistry

BioNTech IMFS, Germantown, Ohio, United States

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Our Analytical Development department in Munich-Martinsried is expanding! We are looking for an experienced Senior Scientist who will design, develop, and implement state-of-the-art and new and inventive mass spectrometry (MS) assays for the characterization of therapeutic messenger RNA (mRNA). Your main responsibilities are: Lead the development and optimization of high-resolution LC-MS methods (e.g., Orbitrap, TIMS-TOF) for intact mRNA, oligonucleotide fragments, nucleoside modifications, and related impurities Design and execute sample-preparation workflows (enzymatic digestion, chemical derivatization, solid-phase extraction, etc.) to enable sensitive and robust mRNA analysis Translate research-grade methods into phase-appropriate, GMP-compliant assays; draft qualification/validation plans, and analytical reports for regulatory submissions (IND/CTA, BLA/MAA) Act as analytical SME by providing expert knowledge for internal and external key stakeholders. Support regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions Provide technical mentorship to junior scientists, research associates, and interns What you have to offer: Ph.D. (or equivalent industrial experience) in Chemistry, Biochemistry, Pharmaceutical Sciences, Molecular Biology, or related discipline ≥ 10 years extensive knowledge in method development and data acquisition and analysis with high-resolution mass spectrometers; at least 2 years focused on RNA, oligonucleotide, or nucleic-acid-based therapeutics Deep understanding of mRNA structure, chemical modifications, degradation pathways, and formulation impact Working knowledge of ICH, USP, Ph. Eur., and FDA/EMA expectations for analytical methods and GMP laboratories Demonstrated ability to solve complex problems, successfully manage projects from initiation to completion, and collaborate effectively with cross-functional, multicultural teams to achieve shared goals Excellent written and verbal communication skills in English. Proficiency in German is desirable We offer a dynamic workplace that embraces diversity in all its forms. BioNTech is committed to creating a diverse and inclusive work environment and is proud to be an equal opportunity employer.

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