Sanofi Group Associate Scientist, In-Process Analytical Testing in Westborough, Massachusetts
Associate Scientist, In-Process Analytical Testing
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.
The Associate Scientist position of In-Process analytical testing team is part of Process Science in Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston. Global MSAT function within Specialty Care Operations assures robustness and economics of cell-culture based manufacturing process in support biologics products Life Cycle Management Strategy (LCM) by
Driving next generation LCM process development and support key strategic initiatives (such as Facility of Future)
Leading Tech transfer, scale-up development and adaptation, control strategy implementation, process validation, comparability for Specialty Care biologics introduction at Sanofi and external Industrial sites
Owning process control strategy of licensed products and providing technical assistance and partnership to commercial manufacturing and QC at Sanofi and external sites including change assessment, process monitoring, troubleshooting and continuous improvement for drug substance
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 expressed from mammalian cell systems.
POSITION OVERVIEW / KEY RESPONSIBILTIES\
The Associate Scientist of In-Process analytical testing will provide analytical support for cell culture and purification development in the newly established MSAT lab. The successful candidate will also support the transfer of in-process analytical tests, and/or improve existing method as needed. The In-Process Testing team is part of the Drug Substance Manufacturing Process Science group. The successful candidate is responsible for performing following duties:
Contribute to establishing an in-process testing lab with focus on routine testing support for cell culture or purification of proteins produced from mammalian cell culture technology within Global MSAT
Support assay protocol transfer and establishment such as lab procedure, sample preparation, test qualification for process intermediate samples, equipment qualification, data report, sample management, and general good documentation practice.
Work with process team to define the requirements of the in-process tests in order to support lab scale experiments; ensure a sufficient assay throughput to enable the process lab capabilities; improve method as needed to better serve the process development needs within the analytical platform scope.
Participate in process development and process improvement work as needed.
Contribute to internal documentation and preparation of reports required for regulatory documents.
- Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
- Degree in life sciences, engineering or other relevant discipline
- BS or MS with 2 years of professional experience
- Minimum of 1 year of hands-on experience in analytical development/support for biologics.
Knowledge in antibody structure, function and characterization
Hands-on experience with cIEF, CE-SDS, Elisa, qPCR, , glycosylation analysis, and other spectroscopy and HPLC based methods
Prior experience in analytical service coordination, sample management, SOP/LP documentation, and data track system
Prior knowledge in Mab process development and manufacturing
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 manufacturing organization
Makes decisions – Makes decisions when needed even if outcomes are difficult, accepts accountability for results and makes choices using sound judgment
Commit to customers- Understands meet and exceed internal and external customer expectations
Act for Change – Drives a continuous improvement mindset & develops high levels of employee engagement#LI-GZ
Job: Engineering & Maintenance
Primary Location: United States-Massachusetts-Westborough
Job Posting: Feb 24, 2017, 11:54:34 AM
Job Type: Regular
Employee Status: Regular