Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals 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. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme 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. Learn more at www.genzyme.com.
Job Responsibilities/Department Description:
The Clinical Laboratory Sciences Department is seeking a Staff Scientist II to join the Clinical Assay Development group. Major responsibilities include development of cell based assays and flow cytometric methods to support late stage drug development in clinical trials (Phase I to III) and post-market programs. Assays include (but not limited to) cell based functional assays (proliferation, cytokine production, and luciferase response), viral infectivity assays, enzyme uptake methods, multi-color flow cytometric cell phenotyping, cell surface receptor occupancy method, and PK assays.
-Ph.D. in life sciences (Cell Biology, Immunology, Biology, Biochemistry, etc) with 3-5 relevant experience, including:
-In depth knowledge in cell biology and strong technical skills in development of cell based methods and multi-color flow cytometric methods.
-Hands on experience in flow cytometry instrumentation.
-Working under minimal supervision.
-Supervisory and management experience.
-Demonstrated contributions to scientific literature and conferences.
-Good verbal and written communication skills. Well organized. Timeline driven.
-Relevant industrial experience in biotech and pharmaceutical companies.
-Has worked in a compliant laboratory environment (GLP, GMP, or CLIA).
-Familiar with regulatory agency's guidelines and published white papers on method development and validation.
-Has used Quality by Design (QbD) or Design of Experiment (DOE) approaches to optimize analytical method.
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