Associate Director, Drug Substance

Associate Director, Drug Substance

Location:

Cambridge, 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.

The Commercial Process Development team, part of the CMC Synthetics Platform within the Sanofi R&D organization, is responsible for mid-to-late-stage process development for drug substances undergoing clinical development and for the chemical process to deliver the drug substance quality target profile. The Chemical Process Development team will own the eco-design strategy for the drug substance and, in collaboration with Analytical Sciences, Process Engineering and Clinical Manufacturing/External Technologies, define the control strategy for the DS synthetic process.

We strongly believe that innovation in synthetic concepts and technologies, leveraging modeling, AI/ML and integration of biocatalysis are key drivers to transform drug substance process development to deliver drug substances in the most efficient, robust, economical, environmentally benign, and intrinsically safe way.

We are looking for a highly motivated and collaborative individual with expertise in synthetic organic chemistry, late-stage clinical and/or commercial development experience to join our growing Commercial Process Development team as an Associate Director. Under the direction of the Head of the Commercial Process Development, the primary responsibility of this role is to design and oversee lab-based studies to support drug substance commercial route evaluation and selection, and process optimization with the aim of generating data packages to successfully transfer technology into GMP pilot plant and manufacturing sites.

Experience in the utilization of technical risk assessments throughout development to guide and prioritize process optimization studies to deliver robust drug substance manufacturing processes that meet Sanofi’s eco-design and economic targets and undergo successful process validation is a must. This individual may be responsible for the professional development of one or more scientists.

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?

• Contribute to the design of novel and efficient synthetic pathways for drug substances undergoing clinical development
• Conduct and oversee route scouting in laboratory to demonstrate synthetic viability
• Use all imaginable chemistry tools and methods to develop and optimize commercial process for selected drug substance route (photochemistry, biocatalysis, flow chemistry, electrochemistry, on-line analysis/PAT, high-throughput experimentation, structural analysis, computational chemistry, etc.)
• Design, plan and execute experimental plans to optimize reaction, purification and isolation unit operations, guided by technical risk assessments, to deliver safe, efficient, robust and scalable drug substance manufacturing processes that perform reliably at intended scale in batch or continuous format
• Collaborate within project teams by working closely with analytical chemists, process engineers, pilot plant experts and project managers within the CMC Synthetics organization
• Communicate scientific results in a clear, concise, and accurate manner via electronic laboratory notebook documentation, development reports, project discussions and presentations
• Lead tech transfer of processes to the pilot plant and manufacturing sites including support for technical and HSE risk assessments, review of Master Batch Records, and campaign coverage for key batches as appropriate
• Provide concise technical presentations to communicate work to project teams, cross functional teams and management. Document all work on projects and continuous improvements in eLNB experiments and summarize in technical…