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Full-timeDescriptionSUMMARYResponsible for executing experiments related to biologics drug substance and drug product development, including but not limited to upstream and downstream support, formulation development, stability program design and execution to support CDMO activities. Performs experiments and relevant analytical techniques that contribute to project goals.JOB RESPONSIBILITIES Essential ? Effective application of basic scientific principles in biologics process and dug product development, analytical/biophysical characterization, drug substance and drug product configuration, delivery compatibility, technology transfer, and stability program design activities associated with the development of biopharmaceutical formulations.
? Executes basic scientific experiments which contribute to project milestones. ? Apply engineering and scientific principles in clone selection, process definition, process optimization, scale-up, technology transfer, process characterization, and process validation activities associated with the cell culture of biopharmaceuticals. Design and perform a series of bench scale or high throughput experiments related to mammalian/microbial cell culture development and scale up such as media selection and feed strategy.
? Designs and perform a series of bench scale experiments such as sterile membrane filtration, depth filtration, tangential flow filtration, viral clearance filtration, as well as chromatography. ? Performs analytical test methods including but not limited to spectrophotometry, pH, liquid chromatography and capillary electrophoresis. ? Performs basic troubleshooting of assays, instrumentation, and equipment. ? Contributes to stability program transfer from analytical development to quality control..
? Contributes to the drug substance and drug product filling process transfer to manufacturing... ? Consistently demonstrates scientific soundness in the laboratory. Supplementary Responsibilities ? Collaborates with cell culture, purification, drug product development, analytical development, QC, and manufacturing for achievement of project tasks. ? Effectively communicates experiment goals and results within the formulations group. ? Interact with other functional groups on specific tasks. ? Other duties may be assigned.
? Authors internal reports at appropriate milestones with supervisory guidance.Salary Description88,400 - 105,000
