Manufacturing and Supply
Wo Wunder der Wissenschaft
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Job Title: Scientist

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.

The Scientist, Downstream Process Development in MSAT will work in a matrix team management environment with global engineers and scientists to achieve robust and scalable purification processes to support 2nd generation processes, late-stage programs, and life-cycle management. This position will support the development of purification processes for a wide variety of molecules and modalities.

In concert with Sanofi’s Patient First philosophy, this role will play a key role in developing robust and scalable protein purification processes to deliver to the manufacturing group. As part of the MSAT group, this position will also support the manufacturing team to ensure the successful technology transfers to produce pharmaceutical drugs for life-saving therapies.

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within the Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next-generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, preparing dossier sections, & PAI support to enable the launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins, and nanobodies. In recent years we have successfully established second-generation manufacturing processes with a continuous process platform. We are pursuing future innovations such as digital labs, factories of the future, and advanced analytics-based process understanding and control.

RESPONSIBILITIES:

• Work with a global group of engineers and scientists to develop robust and scalable downstream processes for monoclonal antibodies, bispecific antibodies, Fc-, Fab-, fusion proteins, enzymes, and other recombinant proteins to support GMP manufacture.
• Work on MSAT development and pilot-scale projects, including regular team meetings and updates for, data management, investigations, technical report writing, and regulatory filings.
• Ability to overcome challenges, with creative and innovative solutions.
• Support the Develop and implement new cutting-edge technologies, for DSP sciences for life cycle management projects.
• Support technology transfer including projects for internal and external partners.
• Support DOE studies to establish proven and acceptable ranges (PAR) for process characterization.
  

About You

• Earned Master's degree in Biotechnology, or related field, with a minimum of 1+ years of relevant experience; OR Bachelor's degree in Biotechnology, or related field, with a minimum of 3+ years of relevant experience.
• Downstream processes at the small to an intermediate scale of cGMP biologics production.
• Experience with chromatography and/or TFF including, UD/DF, micro filtration, nano filtration, and filtration
• Process scaling and/or technology transfer experience is preferred.
• Virus clearance studies exposure is helpful
• Experience working with automated chromatography platforms (e.g., GE Healthcare AKTA) would be ideal
• Experience authoring and executing protocols, as well as interpreting data, and report generation is preferred.
• Experience operating and troubleshooting process equipment is also ideal.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.