Global Head, BioAnalytics, CMC Development

Role Summary

Global Head, BioAnalytics, CMC Development leads analytical development, characterization, innovation, and testing for Sanofi Pharma R&D's biologics pipeline, including mammalian and microbial proteins and genomic medicines, across sites in France, Germany, and the USA. Reports to the head of Global CMC Development. Oversees modalities and activities from research engagement to regulatory submissions.

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).

Qualifications

• 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.

Skills

• Visionary Leadership: Define a clear strategic direction for BioAnalytics that embraces scientific leadership and digital innovation; inspire and motivate teams.
• Change Management: Drive technological adoption and new ways of working in scientific environments; foster adaptability.
• Cross-functional Influence: Collaborate across functions globally; build and maintain relationships with key stakeholders.
• Talent Development: Develop team capabilities in emerging digital technologies; mentor and coach team members.
• Scientific Depth: Develop analytical methods and advanced characterization for diverse biologics; knowledge of bioanalytics and attribute sciences; contribute to patents, publications, and presentations.
• Digital Acumen: Understand automation, robotics, data analytics, AI, GenAI; leverage digital tools to enhance efficiency and structure-function understanding.
• GMP Experience: Knowledge of cGMP; lead GMP function; transfer analytical methods to commercial QC; regulatory compliance.
• Drug Development: Navigate regulatory requirements for approvals and submissions.
• Team Leadership: Lead CMC teams across pipeline projects with broad understanding of CMC and broader development context.

Education

• Ph.D. in related field required.

Additional Requirements

• Languages: English required; French and/or German a plus.