Purpose

Performs 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. Uses 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. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Responsibilities

• Shipping finished materials
• Maintaining inventory levels
• Sampling of in process and raw materials
• Running glass washer / autoclave
• Buffer / media preparation
• Equipment preparation (CIP/SIP)
• Cell culture (from vial thaw to production scale)
• Column chromatography
• Tangential flow filtration