Associate Director, Drug Substance

Role Summary

Associate Director, Drug Substance, based in Cambridge, MA. Leads lab-based studies to support drug substance commercial route evaluation and selection and to optimize processes for transfer to GMP pilot plants and manufacturing sites. Applies expertise in synthetic organic chemistry, late-stage clinical and/or commercial development, and technical risk assessments to deliver robust, scalable, and environmentally responsible manufacturing processes that meet Sanofi’s eco-design and economic targets. May oversee the professional development of one or more scientists.

Responsibilities

• 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 reports
• Establish/extend external network by providing representation and leadership on academic, industrial, or government sponsored collaborations. Steer collaboration projects to address gaps in scientific knowledge
• Champion continuous improvements through pursuit of scientific and technical innovations, workflow optimizations, and incorporation of digital tools

Qualifications

• Ph.D. in organic chemistry with a minimum of 8 years of experience or a master’s degree with a minimum of 12 years of experience in process chemistry and/or commercial manufacturing organizations within the pharmaceutical industry
• Proven track record of developing and mentoring others to develop multi-step processes to consistently produce DS with required quality attributes using batch and continuous platforms
• Demonstrated experience leading drug substance teams through late-stage clinical and process validation (PPQ)
• An ability to operate with flexibility as part of a team in a dynamic environment with tight deadlines, engaging other scientists with complementary skill sets
• Strong leadership, communication and presentation skills
• Play to win mindset
• Familiar with the use of design of experiment, statistical and/or thermo-kinetic modeling to optimize and characterize chemical processes
• French language skills