Associate Director, Analytical Chemistry | Chemist (m/w/d)
BioNTech SE
Job Summary
This role seeks an experienced Senior Scientist to join the Analytical Development department in Munich-Martinsried as an Associate Director of Analytical Chemistry. The primary focus is designing, developing, and implementing state-of-the-art high-resolution mass spectrometry (MS) assays, specifically LC-MS methods (e.g., Orbitrap, TIMS-TOF), for the comprehensive characterization of therapeutic messenger RNA (mRNA). The successful candidate will act as a technical lead, driving strategies from early feasibility through GMP validation and tech transfer to Quality Control. Key responsibilities include optimizing complex sample preparation workflows (e.g., enzymatic digestion), translating research methods into GMP-compliant assays, and drafting critical regulatory documentation for submissions like IND/CTA and BLA/MAA. The position requires extensive knowledge in high-resolution MS and deep expertise in nucleic acid-based therapeutics, along with a strong understanding of international GMP expectations, offering a unique opportunity to shape the next generation of RNA therapeutics.
Required Skills
Education
Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Molecular Biology, or related discipline (or equivalent industrial experience)
Experience
- 10+ years in method development, data acquisition, and analysis using high-resolution mass spectrometers
- At least 2 years focused on RNA, oligonucleotide, or nucleic-acid-based therapeutics
- Professional experience managing projects from initiation to completion
- Experience translating research-grade methods into phase-appropriate, GMP-compliant assays
- Professional experience providing technical mentorship to junior scientists
Languages
Additional
- Must possess 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 required. Must be able to draft qualification/validation plans and analytical reports for regulatory submissions.
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