Senior Biohemistry Analyst

Kelly Science is seeking a Senior Biochemistry Analyst for a consultation position for a growing company located near Princeton, NJ.
Pay: $50-60/hour depending on experience
Employment Type: 6 month contract with possible extension
Job Duties: Perform quality control chemistry assay validation and transfer activities. Lead method transfer and method validation activities which include protocol preparation and execution and report preparation. Testing of drug substance and drug product release and stability samples and reporting results in support of manufacturing operations. Provide support with general laboratory operations including instrument qualifications and maintenance, writing new SOPs and revising existing SOPs, determining and revising existing specification requirements, and documentation of testing records. Take lead on laboratory investigations such as OOS, OOT, deviations, invalid assays, and associated corrective actions. Assist with internal and external audits when needed. Qualifications: Bachelor's degree in chemistry, biochemistry or a scientific related field5+ years of industry experience within a FDA-regulated biotechnology or pharmaceutical company. Extensive experience with the following techniques and instrumentation for quantification, assay validation and transfer activities are required; residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF) Strong knowledge of cGMP, USP/EP and ICH guidelines. Interested? Please apply today for immediate consideration!
9389617