R&D
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About Sanofi
Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our Global CMC Development function within Global R&D covers multiple modalities, including synthetic molecules, mammalian and microbially expressed proteins, as well as genomic medicines. Our mission is to enable new modalities, make our processes robust and sustainable, and our products accessible and convenient.

The Position
The Global Head of BioAnalytics is responsible for all aspects of analytical development, characterization, innovation, and testing for Sanofi Pharma R&D's biologics pipeline. This includes mammalian proteins (e.g., mAbs, multi-specifics), microbial proteins (nanobodies), and genomic medicines (AAV, non-viral LNPs), with teams in France, Germany and the USA. Reporting to the head of Global CMC Development, this highly visible role has the potential to make a significant impact on Sanofi and the patients we serve.

Key Responsibilities

• Develop a long-term strategy and clear vision to enable a broad range of modalities and technology evolution, consistent with the CMC Development strategy.

• Drive continuous improvement to simplify ways of working, harmonize practices between sites, and enhance speed and efficiency.

• Focus on advanced technology development and implementation to enhance attribute knowledge and criticality assessment, and improve external recognition through publications, presentations, and patents.

• Collaborate extensively across other CMC functions (e.g., Mammalian and microbial DS platforms, Bio DP, Synthetics, Data Sciences and Project Management) and with other Sanofi functions (e.g., Research, Quality Assurance, Regulatory Affairs, Manufacturing & Supply, Business Development).

Scope of the Role

• Clinical Stages: From engaging with Research to selecting the most appropriate candidate molecules for development, through progressing projects through all stages of clinical development, transferring analytical methods to commercial manufacturing, and finally leading to approval of regulatory submissions (BLA’s) in major geographies.

• Modalities: Oversee all biologics modalities, including mammalian proteins, microbial proteins, AAV, and non-viral gene delivery.

• Scientific Areas: Includes biophysical methods, biochemical methods, immunoassays, and bioassays.

• Activities: Lead method development, qualification, validation, methods transfer, control strategy development (including specification setting), GMP testing, in-process and characterization testing, and quality/regulatory documentation. Includes raw materials, in-process materials, drug substance, and drug product.

About You

• Education & Experience: Ph.D. in Chemistry, Biochemistry, Biologics Sciences, Chemical/Biochemical Engineering or a related field.  At least 15 years of relevant industrial experience, including 5 years managing a large team (>100) of scientists. Global leadership experience leading and influencing multi-cultural teams with demonstrated ability to bring biological molecules to market.

• Soft Skills:

• • Visionary Leadership: Ability to define a clear strategic direction for BioAnalytics that embraces scientific leadership and digital innovation. Inspire and motivate teams to achieve ambitious goals.

  • Change Management: Proven experience driving technological adoption and new ways of working in scientific environments. Ability to foster a culture of adaptability.

  • Cross-functional Influence: Strong ability to collaborate across functions, preferably globally, to achieve common goals. Build and maintain effective relationships with key stakeholders.

  • Talent Development: Commitment to developing team capabilities in emerging digital technologies and fostering a culture of continuous learning. Mentor and coach team members to reach their full potential.
    

• Technical Skills:

• • Scientific Depth: Demonstrated ability to develop analytical methods and advanced characterization techniques for a large number of therapeutic biologics of different modalities (mAbs, fusion proteins, bispecifics, etc.). Strong scientific knowledge of bioanalytics and attribute sciences, leading to innovative phase-appropriate control strategies. Demonstrated passion for scientific innovation through patents, publications, and presentations.

  • Digital Acumen: Demonstrated understanding of digital technologies, including automation, robotics, data analytics, AI, and GenAI and the ability to leverage digital tools to enhance operational efficiency and understand structure-function relationships of biological molecules.

  • GMP Experience: Knowledge of cGMP and experience with leading a GMP function. Experience in transferring analytical methods to commercial QC. Ensure compliance with regulatory standards.

  • Drug Development: Development of products leading to successful regulatory approvals, demonstrating a thorough knowledge of regulatory requirements from various health authorities. Ability to navigate complex regulatory landscapes and ensure timely submissions and approvals.

  • Team Leadership: Experience leading CMC teams for pipeline projects, demonstrating a broad understanding of other aspects of CMC, as well as the broader context of clinical, non-clinical, and commercial aspects of drug development.

Languages: Fluency in English is a must; fluency in French and/or German is a plus.To be finished

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