Use and apply knowledge of basic scientific principles, theories, and concepts to develop solutions to problems of moderate complexities. Carry out lab work including the recording, evaluating, and analyzing and interpreting data. Contribute to concept and design of research proposals. Present ideas for modifying existing procedures and suggest alternative methods to improve results. Prepare and organize data for presentation at internal meetings. May train new or less experienced employees.
The data reviewer is responsible to assure the quality of laboratory data. This is accomplished by reviewing HPLC/ GC chromatographic data and related notebooks as specified by Standard method of analysis and SOPs.
Review the analytical method verification and transfer testing and ensure that the testing is conducted as per approved protocols and methods. Review Bulk samples, final finished product, Raw Materials, cleaning validation test results for accuracy and completeness. Review and revise SOPs, which are associated with laboratory system.
This position supports the development of scientifically-sound, robust, and transferrable analytic methods for new generic pharmaceutical products. Applying a working knowledge of Method Development Science theories, practices and concepts, the incumbent works under the direct supervision of more senior R&D scientists to execute, and manage product formulations projects. Insure Standard Operating Procedures and protocols are maintained and applied.
The Senior Scientist, Analytical Development will be responsible for establishing analytical strategies, techniques and approaches in support of process and product improvements for engineered cell products (NK) and ancillary materials. Individual will develop and implement analytical approaches to assess the phenotype, function, potency, and functional attributes of engineered NK-cells with the aim of establishing appropriate characterization and analytical control strategies.