Global Head of Process Engineering - Synthetics_ all genders

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

Title: Global Head of Process Engineering – Synthetics

Location: Sisteron, Montpellier – France / Cambridge, US

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. Join our Synthetics CMC Development team in R&D as a Head of Process Engineering and you’ll contribute to our mission to serve patients, while enjoying lots of opportunities to broaden your experience and hone your skills.

Within R&D, our Synthetics CMC Development team is managing all aspects of synthetic/small molecule drug development, from candidate selection to product approval. This encompasses drug substance (DS), oral drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our mission is to serve patients through relentless innovation in synthetic drug development and by designing state of the art manufacturing processes. To this end, our development model is focused on speed to clinic for early-stage programs and delivering safe, robust, and eco-designed late-stage and commercial processes.

Main responsibilities:

• Reporting to the Global Head of Synthetics CMC Development, you will be a member of the Synthetics Leadership Team, responsible for devising the science, innovation, and CMC strategy for all synthetic/small molecule drug candidates.
• You will lead a global organization (~50 FTEs in France/USA) responsible for applying cutting-edge process engineering principles across both drug substance (DS) & drug product (DP) design.
• You will drive the development of innovative, efficient, environmentally friendly, cost-effective, and phase-appropriate DS/DP manufacturing processes for Sanofi’s small molecule R&D pipeline.
• You will be responsible for supporting clinical/commercial process development, risk assessments, QbD (Quality by Design) control strategy, tech transfer, scale-up and process performance qualification/validation.
• You will develop and deploy advanced technologies for automated experimentation, robotics, lab informatics, predictive modeling, crystallization, integration of process analytical technologies, kinetic/mechanistic analysis of synthetic transformations.
• You will drive the application of artificial intelligence & machine learning tools for process simulation and optimization.
• You will establish technology platforms for activities such as DS/DP continuous manufacturing, process safety/thermal hazards evaluation, unit operation modeling, development of digital twins, crystallization, solubility enhancement, rapid formulation development, and process characterization.

About you:

• Educational Background: Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or equivalent with 10+ years in pharma/biotech.
• Scientific Achievements: Strong track record with peer-reviewed publications, patents, and scientific conference presentations; extensive network in academia and industry.
• Strategic Leadership: Proven ability to create vision, develop strategy, align resources, manage execution, and adapt to achieve goals.
• Drug Development Experience: Expertise in pre-clinical, clinical, and commercial phases, including process design, characterization, validation, and regulatory filings.
• CMC and GMP Knowledge: Deep understanding of CMC aspects of GMP development for both drug substance and drug product, with strong knowledge of quality, regulatory affairs, and manufacturing and supply.
• Proven ability: to deliver effective engineering solutions for drug substances and products, with a strong grasp of solid-state characterization and control (as it relates to drug substances used in solid oral dosage formulations), and a creative approach to enhancing technical capabilities.
• Technical and Project Management Skills: Demonstrated ability to deliver engineering solutions, manage projects, and lead diverse teams in a matrix organization.
• Leadership and Innovation: Proven leadership in managing CDMOs, leading GMP activities, and fostering a culture of experimentation, thoughtful risk-taking, and continual learning.

Why choose us:

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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Location: Sisteron, FR

Posted Date: 11/23/2024