COMPANY DESCRIPTION:
Sanofi-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. Our portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a part of Sanofi, we 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.
Sanofi 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.
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.
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 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 Global Drug Substance Organization with Global MSAT, this position will also be responsible for overseeing routine analytical testing, manufacture support, ensure technical transfer smoothness and process validation stability studies et al.
KEY DUTIES/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
Support technology transfer including projects for internal and external partners
Learn and execute protein stability studies on liquid, frozen, and/or lyophilized formulations
Perform analytical work such as UV spectrophotometry for protein concentration and HPLC (high performance liquid chromatography) for product purity to support in-process sample testing and quality control
Participate in design and execution of experiments using small-scale models, analyze and interpret results, and recommend additional experiments. Utilize this knowledge to expand process understanding and drive improvements in the commercial manufacturing operations including improving process robustness/reliability
Apply design space knowledge to support effective investigations and root cause analysis
Use scientific principles and professional practices to solve a range of complex problems in creative and practical ways
Author protocols, technical reports, data analysis summaries, and SOPs
BASIC REQUIREMENTS / QUALIFICATIONS:
PhD in Biotechnology, or other scientific field, with minimum of 0 to 3 years of similar experience; OR
M.S./M.A. in Biotechnology, or other scientific field, with minimum of 3 to 5 years of similar experience; OR
B.S./B.A. in Biotechnology, or other scientific field, with minimum of 5+ years of similar 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
Understanding of protein stability, characterization, and/or analytical analysis theory
PREFERRED QUALIFICATIONS:
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
Experience in biologics stability studies
Effective communication & presentation skills
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.