Perform testing for in-process samples including: Density, Viscosity, Appearance, UV Spectrophotometry, pH, Osmolality, particulate matter (HIAC and MFI), protein content, and HPLC analysis including, but not limited to, SEC, and Polysorbate 80
· Set-up and operation of most equipment in the formulations and process lab including plunger insertion unit, filler, vial capper, etc.
· Prepare common buffer, calibration, standard solutions as needed; will perform all aspects of laboratory operations, such as sample receipt, data generation, data verification and interpretation, instrument qualification, operation, troubleshooting, and all supporting documentation for such activities
· Complete sample LIMS tasks and interface with other informatics systems within the laboratory as needed to perform testing; plan experiments, author documents relative to those experiments, provide data integrity review for work completed by others
· Responsible for all aspects of assigned studies including securing formulations excipients, components (vials/stoppers and prefilled syringes/plungers), equipment set‑up, manufacture drug product, dialysis, placebos including sampling and equipment clean-up, sample submission, and summarizing the data for the study; maintain laboratory instrument calibration, cleaning, restocking supplies