Global Head, BioAnalytics, CMC Development

Job Title: Global Head, BioAnalytics, CMC Development

Location: Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

About Sanofi
Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our Global Chemical Manufacturing and Control (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 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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.  A

• t 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 digita