DSD Modeling Leader - MSAT

Job Title: DSD Modeling Leader

Location: Framingham, MA

About the Job

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 Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfils an important function by providing day-to-day Manufacturing Support, focusing on technical and process aspects, effective Life Cycle Management, process robustness enhancement, and yield improvement to optimize performance.

Join our global network and contribute to the launch of 3 to 5 new products annually across various modalities, 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.

Under the lead of MSAT and in partnership with many other functions (Manufacturing 4.0, Digital, M&S, R&D), the Process Data Science & Digital team is a transversal team driving Data Sciences innovations, developments, expansion, and integration within MSAT day-to-day operation space and strongly contributes to design the tomorrow’s industrial bio, chemical and analytical processes bridging from R&D to industrial world.

Within Process Data Science & Digital Team, the Mechanistical Modeling and Process Control Platform delivers process modeling to support Quality by Design of new products, accelerates technology and scale transfer activities by numerical comparability approaches and develop techniques for real time process monitoring and control.

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?

Main Responsibilities:

Develop and deploy process modeling to support launches (NPI, NV) and commercial products (2G, LCM, TT and MA)

·Collect and assess business needs from MSAT partners (lab scientists, project leaders, process experts) requiring modeling support for manufacturing Drug Substance (DS) upstream/downstream or Drug Product (DP) processes.

·Define modeling strategy, planning and execute the study including documentation. If needed involve support from suppliers and vendors. Communicate on progress to internal customers and measure added value and gain. Define associated communication plan.

Contribute to process modeling knowledge management, innovation and communication

·Participate in method harmonization, documentation of know-how, and scientific and industrial valorization (patents, publications, training).

·Work effectively with internal, and external stakeholders (R&D, manufacturing, academic and industrial partners) in an international environment.

·Scout and promote innovative modelling approaches and tools to enhance process robustness, performance, and sustainability.

Modeling techniques of application

Offline modeling for process characterization and validation- 30%:

·Computational Fluid Dynamics and Mechanistical-hybrid modeling (mass balance, involving complex physical and biological models (mass, energy, turbulence balances, chemical kinetics, cellular metabolism)).

·Computer-Aided Process Engineering software (gProms), Computational Fluid Dynamics software (Ansys Fluent, M-Star) and CAD solution, Numerical Methods (FEM, FVM, Numerical Integration, Optimization Algorithms, Parallel Computing on Window/Linux), Coding skills (Python, R, Matlab, VsCode) and developing environment (git, github).

Real time modeling for monitoring, testing and process control- 70%:

·Chemometric (NIR/Raman) modeling (MVDA and ML/AI techniques), state observer, Kalman filter, Advanced Process control, Model Predictive Control (MPC), signal processing.

·SIMCA off/online, Process Analytical Technology software’s (SynTQ), Matlab Simulink, Coding skills (Python, R, Matlab, VsCode) and developing environment (git, github).

About You

Education & Experience:

·MSc. or PhD and 3+ years of experience in chemical, bioprocess, or industrial engineering (or a similar technical field) or computer science with a technical expertise in process modeling (mechanistic/hybrid modeling, PAT, process control and automation) – required.

·Experience in GMP or other regulated manufacturing environment - preferred.

Soft and technical skills:

·Process modeling ((mechanistic / hybrid modeling, chemometric modeling e.g. PAT Raman) and control (APC, MPC)

·Strong communication skills, written and verbal with practical results of methods and approaches that have proven effective

·Strong analytical and problem-solving skills, able to take risks to achieve desired outcomes

·Ability to interact effectively with various internal and external stakeholders, including key experts in their fields

·High level of autonomy

·Able to lead/animate networks, teams and experts

Languages:

·Fluent in English (spoken & written)

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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