Set-up and execute cGMP unit operations with a focus on Purification (Chromotography, flow through filtration, tangential flow filtration) and solution formulation. Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc).
Accurately follow oral, written and electronic instructions in the production area and document daily operations in GMP batch records and logs.
Operate manual and automated equipment. Individuals will be expected to learn and work with enterprise system such as LabWare LIMS and SAP.
Support implementation of new technology for process execution and/or analysis.
May be responsible for authoring and revising cGMP documents including batch records and SOPs.
Responsible for data entry and real time process monitoring.
Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
Execution of Purification, Buffer preparation and glass wash activities in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance.
Years of Experience 2-5.
Experience with chromatography columns, UF and VRF systems, flow through filtration, tangential flow filtration, and final fills are preferred.
Successful candidates will be flexible and adaptable, willing to work in a fast paced, dynamic environment.