Position: Scientist Downstream Process Development
Location: 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. With a focus on rare diseases and multiple sclerosis, 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.
JOB OVERVIEW
The Scientist for 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 successful technology transfers to produce pharmaceutical drugs for life-saving therapies.
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, including 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 scale-down models
Support technology transfer including projects for internal and external partners.
Support DOE studies to establish proven and acceptable process ranges.
BASIC QUALIFICATIONS
B.S./B.A. in Biotechnology, or similar Scientific discipline, with a minimum of 2-5 years of relevant industry experience OR M.S./M.A. in Biotechnology, or related field, with a minimum of 3 to 5 years of relevant industry experience AND
Experience with downstream processes at the small to the intermediate scale of cGMP biologics production including chromatography and filtration.
PREFERRED QUALIFICATIONS:
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.