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鈥憉p, 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