Shinji Oyama
Principal Scientist @Adaptimmune
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WORK HISTORY
Principal Scientist @Adaptimmune
Cambridge, MA, US
Leading Analytical Development efforts on multiple projects and overseeing all analytical activities for Process & Analytical Development (PAD) group • Analytical Lead on CMC team on multiple projects including a phase 3 clinical project o Re-establish clinical readiness on a tight timeline on a previously discontinued program o Lead PAD readiness efforts to support clinical readiness - Re-established clinical analytical methods in PAD group, develop Fit for Purpose strategy for assays, cell lines, and controls o Collaborate with CRO for clinical readiness -Develop strategy and transfer re-established Analytical methods, cell lines, and controls to CRO for Phase 3 clinical use o Perform gap and risk assessments, formulate and oversee analytical work packages o Oversee or Author any ROPs/regulatory writings• Support and train junior scientists
EDUCATION
Harvard University Extension School
Master of Arts - MA, Biology
Tufts University
BS, Biology/History
SKILLS
ABOUT SHINJI OYAMA
A scientist with 24 years of experience with a diverse knowledge of various technologies, areas of research, and drug development. Most recently, an Analytical Development Lead at a lentiviral gene therapy company, focusing on Phase 3 readiness. Demonstrated ability to build and mentor scientific teams. A flexible, dependable team player valued for diversity of knowledge and ability to learn swiftly. Demonstrated ability to meet or exceed aggressive deadlines and effectively take on new and multiple roles in dynamic R&D environments.
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