Sanofi Group Process Engineer III, Framingham, MA in Framingham, Massachusetts
Process Engineer III, Upstream
Department Description :
The Process Engineer III position is part of Process Science in Global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Framingham, MA. The Global MSAT function assures robustness and economics of cell-culture based manufacturing processes in support of life cycle management (LCM) of biological proteins expressed from mammalian systems by:
Driving next generation LCM process development & supporting key strategic initiatives
Leading Tech transfer, scale-up development & adaptation, process control strategy, process validation, and comparability at Sanofi and external industrial sites
Providing technical assistance for commercial manufacturing at Sanofi & external sites including change assessment, process monitoring, troubleshooting, and continuous process improvement
Position overview /Key responsibilities:
The Process Engineer III will be a key contributor in the Process Science Upstream group for advancing life cycle management (LCM) of Sanofi’s commercial portfolio. The successful candidate will apply scientific principles and utilize cell culture, bioreactor, and separation technologies to: improve current commercial and develop next-generation processes of monoclonal antibodies and recombinant proteins, with responsibilities spanning bench and pilot-scale process development & characterization, as well as support of technology transfer to manufacturing facilities. The candidate will have a strong chemistry background and a proven track record in one or more of the following areas in an academic or industrial setting: chemometrics, systems biology, process analytical technologies (PAT) and automation. The successful candidate will utilize their knowledge in these areas and advanced statistical analysis to industrial cell culture applications. This individual will work in a team environment, collaborating with colleagues in the MSAT, R&D, and Manufacturing organizations to solve a wide range of complex problems in creative and practical ways.
Specific Responsibilities include:
Work collaboratively within the Process Science team to design, execute, and interpret the results of bench scale experiments; Build understanding and recommend changes or additional experiments
Analyze process development and commercial manufacturing data in support of the MSAT mission
Lead a small project team evaluating LCM improvements for the production of new or existing processes, methods, or technologies, and their implementation in manufacturing / QC facilities
Design, set-up, maintain, and evolve laboratory and MSAT tools /systems, and technical ways of working
Author and review internal documents and reports; support preparation of regulatory documents
Present data and results within department and project teams
May contribute on technology transfer efforts to pilot scale or manufacturing
May provide technical guidance and train junior team members, or lead small teams
Represent Sanofi in the greater biotech community by publishing in peer reviewed journals and through participation in scientific/technical conferences
Perform responsibilities with limited supervision and direction. Participate in determining objectives of assignments. Independently determine and develop solutions. Work is reviewed for soundness of judgement and overall adequacy and accuracy.
*Key responsibilities may differ among employees and change over time, in accordance with business needs
Degree in chemistry, chemical engineering, biochemistry, or equivalent AND the following professional experience in the biotechnology or pharmaceutical industry.
BS and 8 years, or MS and 6 years, or PhD and 0-2 years
PhD and more than two years of professional experience
Excellent scientific background
Proven track record in a specialized area, such as chemometrics, systems biology, PAT and automation, or the equivalent demonstrating successful application of knowledge in chemistry to solve complex problems
Hands-on experience at laboratory, pilot, or manufacturing scale for biologics products
Knowledge in cell culture process development, bioreactor design and control strategies, scale up and scale down as applied to mammalian-expressed proteins
Strong skills in data analytics, statistical modeling, and associated software
Highly motivated individual with the ability to work independently and on cross-functional and cross-site teams.
Some experience in a team environment with other technical staff
Strong technical writing and presentation skills
Some understanding of GMP commercial biologic manufacturing operations
Strives for results: sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets
Cooperates transversally: Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization
Commit to customers: Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization
Act for Change: Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes.
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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