Associate Director Manufacturing Science and Technology

About the position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization. Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year. The Associate Director position is part of 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. 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.

Responsibilities

• Lead a team of scientists and engineers leading multi-product technical support in upstream commercial process operations at the Framingham site.
• Manage a team supporting New Products Introduction, 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.

Requirements

• BS with 13 years, or MS with 10 years, or PhD with 8-year experience in biologics development, bioprocess engineering, technology transfer, and/or commercial manufacturing operations.
• Minimum 3 years of experience managing a technical team and developing people.
• Fluent in English with an excellent scientific and engineering background, good technical writing, and presentation skills.
• Experience managing, coaching, and developing scientific and engineering staff.
• Ability to influence cross-functional and cross-site teams and to effectively communicate with project leaders and department and site management.
• Experience with perfusion and other continuous-based cell culture processes, their development and/or industrial implementation.
• Hands-on experience with mammalian cell culture operations at laboratory, pilot, or manufacturing scale.
• Successful history of leading technology transfers, PPQ, and process control strategy establishment.
• Experience with design and start-up of new facilities, advanced process monitoring, data analysis, and CPV.
• Experience with change assessment, product impact assessment, quality event management, and PQR.
• Experience with authoring regulatory filings and supporting PLI and other health authority inspections.
• Self-motivated with excellent attention to detail and having a proven ability to work in a highly collaborative environment and communicate transversally.
• Flexible with ability to adjust to a fast-paced, goal-oriented environment and willingness to expand and broaden skillset.

Benefits

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