Principal Scientist Mass Spectroscopy Lab Full-time

Mass Spectroscopy Manager/Principal Scientist

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Sanofi is seeking a highly motivated principal scientist in mass spectrometry to join our analytical group. The group is part of the synthetic platform within Global CMC Development that is striving to become an industry leader in the development of transformative medicines.

The primary responsibility of this position is to lead the mass spectrometry laboratory in support to CMC analytical development teams. In this role, you will be responsible for the mass spectrometry characterization for structural characterization and mutagenic and nitrosamine impurities quantitation of synthetic small molecules using HPLC/HRMS and GC/MS as the primary techniques. This position is onsite and is based in Montpellier, France.

Main Responsibilities:

• Manage Montpellier mass spectrometry laboratory. Use resources to develop and implement HPLC/HRMS methods for the structural characterization and structural elucidation by interpretation of fragmentation mass spectra, of synthetic small molecules (active principal ingredient, impurities, and degradants) in the context of CMC development projects and analytical expertise. Manage analytical park (UPLC/HRMS and GC/MS) to ensure availability of state of the art equipment, maintenance and operational qualification of equipment. Ensure the reliability and traceability of results obtained. Review analytical studies performed by mass spectrometry senior experts. Creation and management of open access MS for chemistry support
• Define and implement Sanofi strategy on nitrosamine and mutagenic impurities for Analytical Sciences and CMC development. Analytical expert in nitrosamine/mutagenic quantification by mass spectrometry, in this context develop and validate LC/MS and GC/MS based quantitation methods
• Redaction of the documentation on mass spectrometry related to structural elucidation and mutagenic/nitrosamine impurities analysis including clinical and submission dossier. Participate in regulatory audit (GQA/PAI/ANSM…) as mass spectrometry expert
• Collaborate closely with colleagues in Analytical Sciences, other CMC teams and project management teams. Participate in the scientific meetings of the different projects to bring its expertise in solving analytical problems. Make presentations within and between departments
• Could have to manage projects as Analytical Team lead in Project Team

Skills that you have:

• Experience: Specialist in high-resolution mass spectrometry, you have significant experience of at least 10 years. You have advanced knowledge of the principles, concepts, and practices of various aspects of Mass spectrometry for structural analysis and mutagenic/nitrosamine quantification and growing knowledge of principles and concepts in analytical development
• Education: PhD in Analytical Chemistry
• Technical skills:
• You are familiar with high performance equipment (Orbitrap, QTof, Triple Quad, etc.) and spectrometric data processing software (MassLynx, Xcalibur, Chromeleon) and you are at ease interpreting fragmentation mass spectra (Full scan, MSn)
• GMP and Regulatory (ICH, Pharmacopoeia) knowledge related to mass spectrometry
• Soft skills:
• You have a strong experience in team management to identify and develop scientific activities to support operational goals. You implement new approaches to develop team members and activities (IA, Automation). You plan and prioritize resource requirements and allocations within a functional team
• Provides clear and structured explanation of multi-step studies to other local functions and to other cross-site functional groups. Supports development of group culture by proactive work delivery and positive attitude for both team and individual assignments
• Makes decisions that frequently require developing new options to solve complex problems. Decisions impact project delivery and/or may impact achievement of local group goals
• Ability to manage under high pressure environment and time constraints
• Presents internally for governance and technical meetings. May have publications, patents, or participate in professional consortia. Increasing visibility externally with presentations and publications

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At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.