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Chemist as associate director (m/f/d)

Planegg
BioNTech SE
Director
Inserat online seit: 6 Oktober
Beschreibung

Associate Director Analytical Chemistry Martinsried, Germany | full time | Job ID:9649 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). You will act as a technical lead, shaping strategies from early method feasibility through GMP validation and tech transfer to Quality Control. 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 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 Join us to shape the next generation of RNA therapeutics through cutting-edge analytical science. 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

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