To perform functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
Use sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment and determine and may assist in developing methods and procedures to control or modify the manufacturing process.
Responsible for Cell culture (from vial thaw to production scale), Buffer/ media preparation, column chromatography, tangential flow filtration and sampling of in process and raw materials.
Assigns tasks within the shift team to other biotechnologists.
Assists Supervisor in planning and leading area activities ...