Sanofi Group Process Analytical Scientist, Upstream in Westborough, Massachusetts
Process Analytical Scientist, Upstream
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
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; 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.
DEPARTMENT DESCRIPTION ;
The Process Analytical Scientist position is part of Process Science in Global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston. MSAT within Industrial Operations (IO) of Sanofi Genzyme Specialty Care assures robustness and economics of cell-culture based TMabs manufacturing process life cycle management (LCM) by:
Providing daily assistance to commercial manufacturing and QC such as process monitoring, complex troubleshooting, continuous improvement and training/know-how transfer
Leading IO activities such as Tech transfer, scale-up development/adaptation, process control strategy, process validation, comparability for TMabs products introduction at Industrial sites within sanofi and at partner sites
Driving LCM process development/implementation at industrial sites & support key innovation initiatives
MSAT-Process Science is the process owner of all industrial manufacturing processes, analytical methods and associated process control strategies for antibodies and antibody-like molecules (TMabs) expressed from mammalian systems.
POSITION OVERVIEW / KEY RESPONSIBILITIES :
Process Analytical Scientist will apply her/his solid understanding of scientific principles and professional practices to contribute to MSAT-Process Science mission by performing the following duties in upstream processing:
Analyze existing process and analytical development and commercial manufacturing/QC data to support one or more of MSAT mission
Designs and conducts necessary experiments; Builds understanding and interpretation of results; recommends changes or additional experiments.
Leads a small project team for LCM improvements of methods for the production, purification and testing of new process formulas, technologies and their implementation in manufacturing/QC facilities
Design, set-up, maintain and evolve laboratory, and MSAT tools/systems
Solve a wide range of complex problems in creative and practical ways
Contributes to Build/Adapt & Deployment of best practices and technical way of working within TMabs development and manufacturing teams
Provides technical training and know-how transfers to manufacturing teams
Collaborate with other scientists/engineers across the biologics network of sites within Sanofi and with partnership organizations
Responsible for internal documentation and preparation of reports required for regulatory documents
Support regulatory filings and interaction with authorities as subject matter experts
Present data and results within department and project teams
Represents corporation in the greater biotech community by publishing in peer review journals and participation in scientific/technical conferences.
May contribute to technology transfer efforts of small project team between groups/organizations
May provide technical guidance and trains less experienced staff
Work is performed under general direction. Independently determines and develops approach to solution. Work is reviewed upon completion for adequacy in meeting objectives.
Basic Qualifications :
Degree in life sciences, engineering or equivalent.
BS and 8 years
MS and 6 years
PhD and 2 - 5 years of relevant professional experience
Preferred Qualifications :
Laboratory/pilot or manufacturing skills in upstream processing and associated analytical testing techniques
Knowledge of use of structured methodologies for upstream process design, process control strategies, validation and continuous process verification as applied to mammalian-expressed proteins
Strong understanding of commercial bio manufacturing operations
Experience with working in a team environment with other technical staff
Excellent scientific background and presentations skills
Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams
Leadership Qualifications :
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
Job: Laboratory/Process/Device Development
Primary Location: United States-Massachusetts-Westborough
Job Posting: Oct 21, 2016, 12:32:40 AM
Job Type: Regular
Employee Status: Regular