Scientist II - Upstream Development

Job Title: Scientist II

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’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 per year.

The Scientist II position is part of the Upstream team in the Recombinant Drug Substance (DS) function within global MSAT and is based at the Mammalian Platform hub in Framingham, MA. The Recombinant DS 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 work with a group of scientists and engineers responsible for development & characterization of next generation cell culture processes, technology transfer to a diverse network of manufacturing facilities, and support of advanced manufacturing investigations and process improvements for commercial products. We are looking for a candidate with excellent scientific and communication 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 in creative and practical ways.

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:

• Design and conduct experiments, analyze and interpret data, and present results to department and project teams
• Analyze process development and commercial manufacturing data in support of the MSAT mission, with the aim of improving process robustness, building process understanding, recommending improvements implementable in manufacturing, and developing next-generation processes for monoclonal antibodies and recombinant proteins
• Contribute to/lead a small project team for LCM Upstream process improvements and implementation in manufacturing
• Support technology transfer activities, contribute as process SME, and represent the Upstream team across cross-functional groups and external organizations.
• Contribute to/lead a sub team within Upstream MSAT focused on technical investigations of complex deviations in manufacturing
• Contribute to/lead the establishment of best practices and technical ways of working across internal development and manufacturing teams, as well as with external CRO/CDMO partners
• Mentor Upstream project team members in a matrix-managed setting and provide technical training to lab staff
• Collaborate with scientists/engineers across the biologics manufacturing network within Sanofi and with partner organizations
• Responsible for internal documentation and preparation of technical reports required for regulatory documents.  May support authoring of regulatory filings
• Represent the Upstream team as an SME or technical lead in cross-site, cross-functional teams

About You

Education and Experience:

• PhD with 2 years, or Master with 5 years, or Bachelor with 7 years relevant industry experience in biologics development, bioprocess engineering, technology transfer and/or commercial manufacturing operations – required. 
• Hands-on experience in mammalian cell culture process development at laboratory, pilot, or manufacturing scales
• Expertise in bioreactor design and control strategies, scale up and scale down approaches as applied to mammalian-expressed proteins

Soft and technical skills: 

• Excellent scientific background with strong technical writing and presentation skills
• Proficiency with statistical data analysis and relevant software tools
• Self-motivated and detail-oriented, with the ability to work independently or collaboratively in cross-functional, cross-site teams
• Strong communication skills and effectiveness in highly collaborative, fast-paced environments
• Adaptable and willing to expand and broaden technical skillsets
• Demonstrated ability to become a cell culture SME in a relevant field, e.g. medium development, omics, PAT, cell banking, process intensification, scale up / down, or process automation or miniaturization
• Knowledgeable in other cell culture systems and modalities, such as microbial and insect cell culture or gene / cell therapy

Languages:

• English 

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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