Associate Director, Upstream MSAT

Job Title: Associate Director, Upstream MSAT

Location: Framingham, MA

About the Job

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?

The Associate Director position is part of the Upstream team in the Recombinant Drug Substance function within global Manufacturing Sciences, Analytics, & Technology (MSAT) and is based at the Mammalian Platform hub in Framingham, MA. The MSAT mission is to enable the reliable supply of medicines by providing expert technical and scientific support for their licensure, ongoing commercial manufacturing, and life-cycle management activities.

Join our global network that contributes to the launch of 20 new products in the next 5 years across various modalities and to an expansive portfolio, enabling us to reach and serve more patients and communities. Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi’s best-in-class ambition.

The Recombinant Drug Substance function within global MSAT is the owner of Life Cycle Management (LCM) of DS processes. Implementation of second-generation processes is one of the top performance enablers for Sanofi’s biologics manufacturing network and integral to LCM.  We deliver innovative, robust, and cost-effective next generation processes. In recent years we have successfully established second-generation manufacturing mammalian processes with a continuous process platform. The function is responsible for tech transfer, process validation, dossier preparation, & PAI support to enable launch of new and LCM products. We are pursuing future innovations such as digital labs, factory of the future, and advanced-analytics-based process understanding and control. 

The successful candidate will manage a team of scientists and engineers responsible for tech transfer support of legacy and next generation cell culture processes across a network of manufacturing facilities, process validation support, and commercial manufacturing support of process-related investigations and process improvements for commercial products.  We are looking for a candidate with excellent scientific, communication, and people management skills.  This individual will work in a fast-paced, team environment, collaborating with colleagues across functions in the organization to solve a wide range of complex problems, and leading the Upstream Manufacturing Sciences team to meet department and site deliverables.

Main Responsibilities:

• Lead a team of scientists and engineers comprising the Upstream manufacturing sciences team and oversee their professional development

• Manage a team leading multi-product technical support in upstream commercial process operations at the Framingham site.

• Manage a team supporting NPI, technology transfer, facility fit, FMEA, process validation and process control strategy definition for introduction of new products and processes at manufacturing scale.

• Provide technical leadership in process monitoring, CPV, root cause investigation, change assessment, product impact assessment, and continuous improvement.

• Coach a technical team utilizing a solid understanding of scientific principles and professional practices to solve a range of complex deviations and technical issues in manufacturing in creative and practical ways.

• Represent MSAT management in interactions with Engineering, Manufacturing, Quality, and other site stakeholders.  Provide input and advice on process-related investigations and LCM process improvements.

• Author and support regulatory filings and health authority inspections. Coach a team responsible for preparing reports and other internal documentation for regulatory purposes.

• Collaborate with MSAT and CMC Development colleagues across the global biologics manufacturing network on NPI and tech transfers, process adaptations for facility / equipment fit, and process design and control strategy definition, with a broad range of SMEs and leaders in upstream, downstream, analytical, pilot plant, biostatistics, and modeling functions.

About You

Experience and Education:

• Degree in life sciences, engineering, or other relevant degree

• Minimum years of experience: BS with 1