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Sanofi Group Scientist, Downstream Process Development in Framingham, Massachusetts

JOB OVERVIEW

The Scientist, Downstream Process Development in MSAT will work in a matrix team management environment with global engineers and scientists to achieve robust and a 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 technical 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 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, prepare dossier sections, & PAI support to enable 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 launch of 20 new products in 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 process with continuous process platform. We are pursuing future innovations such as digital labs, factory of 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-, and fusion proteins, enzymes, and other recombinant proteins to support GMP manufacture.

  • Work on MSAT development and pilot-scale projects, to include regular team meetings and updates for, data management, investigations, technical report writing and regulatory filings.

  • Support virus clearance studies to support regulatory filings including establishing of scale-down models.

  • Support technology transfer including projects for internal and external partners.

  • Support DOE studies to establish proven and acceptable process ranges.

Basic Requirements/Qualifications:

  • PhD in Biotechnology, or related field, with minimum of 0 to 3 years' of relevant experience; OR

  • M.S./M.A. in Biotechnology, or related field, with minimum of 3 to 5 years' of relevant experience; OR

  • B.S./B.A. in Biotechnology, or related field, with minimum of 5+ years' of relevant experience

AND

  • Experience with downstream processes at the small to intermediate scale of cGMP biologics production including chromatography and filtration.

  • Prior experience in process scaling and or technology transfer.

  • Prior experience with automated chromatography platforms (e.g. GE Healthcare AKTA).

  • Experience with authoring and executing protocols, interpretation of data and generating final reports.

  • Process-scale chromatography and filtration including Nano, tangential flow, and normal flow filtration.

  • Experience writing and revising standard operating procedures and batch production records.

  • Experience with operating and troubleshooting process equipment.

  • Experience working on late phase and commercial programs.

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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