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Sanofi Group Senior Scientist/Manager in Framingham, Massachusetts

Position: Senior Scientist/Manager

Pilot Plant: Framingham, Massachusetts

COMPANY DESCRIPTION:

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. These goals are accomplished through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. We are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

Sanofi, an integrated global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with growth platforms in human vaccines, innovative drugs, consumer healthcare, emerging markets, rare diseases, gene therapies and animal health.

Genzyme Corporation, a Sanofi company 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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

JOB OVERVIEW:

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.

We currently have multiple job openings at different levels at Massachusetts, US site and Vitry, France site

The Senior Scientist/ Manager position for the Downstream team in the Pilot Lab will work in a matrix team management environment with global engineers and scientists to achieve robust and scalable processes to support 2nd generation process scale-up, tech transfer and life-cycle management. The position also involves the management of 2 downstream Scientists.

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.

Responsibilities:

  • Work with/ Lead a group of engineers and scientists to develop robust and scalable Downstream processes for multiple modalities

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

  • Support technology transfer including projects for internal and external partners

  • Support DOE studies to establish proven and acceptable process ranges

REQUIREMENTS:

  • PhD in Biotechnology, or related field, with minimum of 6 years of relevant experience; or

  • M.S./M.A. in Biotechnology, or related field, with minimum of 8 years of relevant experience; or

  • B.S./B.A. in Biotechnology, or related field, with minimum of 10+ years of relevant experience

  • Experience with Downstream processes at Pilot scale strongly preferred

  • Prior experience in process scaling and or technology transfer is strongly preferred

  • Prior experience with automated systems a must

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

  • 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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