Corey Hooker Email & Phone Number

United States

I manufacture media in the Gene therapy department. I'm responsible for managing my own time, professional development and to be accountable for my own results. I prioritize my own workflow, may lead and allocate work of others and assist in establishing their priorities. Responsible for providing input for performance assessment of team members. Conduct all activities in accordance with Company policies & Standard Operating Procedures, global regulatory guidelines, and environmental guidelines. Advise management of non-conformance issues and opportunities for continuous improvement. Monitor routine production preparation tasks. Subject matter expert for filter integrity testers.

Durham, North Carolina

I am responsible for execution and assisting in the design of Process Development experiments. Responsibilities involve day-to-day biopharmaceutical experiment execution, documentation, and coordination and process efficiency improvements. Tasks/Responsibilities: Provide help in identifying and developing new processes, assist with the design and execution of process scale-up and process optimization experiments under manager’s supervision. Assist with the technology transfer from the development group to the manufacturing group as needed. Summarize results in development reports and presentations. Assist the manufacturing group with SOP, STM and Batch Record writing. Assist the manufacturing group with resolution of process deviations and change control. Assist with the maintenance and day to day operation of the Process Development lab. Able to collaborate closely with colleagues outside my immediate department to meet critical production timelines.

Holly Springs, North Carolina

I was a shop floor employee in the manufacturing organization. I provided the technical skill sets necessary to manufacture high quality biologicals and/or sterile injectables safely in a compliant, efficient, and cost effective manner. I am proficient on processes and equipment and serve as a hands-on resource in production. I was responsible for cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Operation and sterilization of 20L, 200L, 1500L, and 5000L bioreactors. Use of Vi-cell and GLA equipment. Proper sampling techniques and performance of cell metabolism monitoring. Execution of process steps according to defined SOPs and BPRs. Documented activities in accordance with cGMPs. Handled biologically and chemically hazardous goods. Interfacing with process automation systems and electronic business systems (e.g., PAS, BAS, PLCs, LIMS, SAP, Live Link)

Durham, North Carolina

Responsibilities Performed various operational tasks as part of an empowered team: (30% - Clean Room Mgt/Materials) Set-up & breakdown of (GMP) space/equipment, accurately & efficiently moved process materials in accordance w/ procedure. Worked in compliance w/ procedures, doc.'s, gov. regulations, safety programs (appropriate SOP's), follow lean mfg principles & current mfg practices (cGMPs). Managed inventory & tasks for aseptic growth. Equipment prep & movement. (60% - Operations Support) Operates/monitors equipment (incl. but not limited to ; RCCS, shell freezers, Wheaton Carts, Tube Welders, Pooling equipment, Filler Machine) as deemed by skill level to set QC status & expiry of sterile equipment, provides materials & support/maintenance of equipment, systems knowledge (SAP, MES, Kanbans, PLC), sample delivery