World class pharmaceutical company seeking MS or PhD scientist to develop strategies for identifying disease and drug related biomarkers, translational strategies, and companion diagnostics.
*** Conceive, initiate, and execute biomarker strategies for Oncology therapeutics in various stages of clinical development.
*** Identify and implement biomarker assay procedures.
*** Analyze pharmaco-dynamic data from various platforms including Immunohistochemistry (IHC), Fluorescent In-situ ...
Manage regulatory affairs department and drive quality & regulatory compliance initiatives, while improving quality systems for bio-pharmaceuticals manufacturer.
*** Direct Quality & Regulatory function for manufacturing operations.
*** Ensure compliance with local, federal and global quality system regulations applicable to products sourced, manufactured, or distributed by facility.
*** Implement and oversee Corrective and Preventative Action program, validations, inspections, ...
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