Associate Director, Drug Substance jobs in United States
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Sanofi · 3 hours ago

Associate Director, Drug Substance

Sanofi is an innovative global healthcare company focused on improving people’s lives through science. They are seeking an Associate Director for their Commercial Process Development team to design and oversee lab-based studies for drug substance commercial route evaluation and selection, ensuring efficient and robust manufacturing processes.

Health CareLife SciencePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

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

Qualification

Synthetic organic chemistryProcess optimizationTechnical risk assessmentsDesign of experimentsStatistical modelingFrench language skillsLeadership skillsCommunication skillsPresentation skills

Required

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

Preferred

French language skills

Benefits

High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave

Company

Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.

H1B Sponsorship

Sanofi has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)

Funding

Current Stage
Public Company
Total Funding
$6.97B
Key Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B

Leadership Team

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Paul Hudson
Chief Executive Officer
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Francois-Xavier Roger
Chief Financial Officer
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Company data provided by crunchbase