Lee Panter Email & Phone Number

Cleveland, Ohio, United States

Generated and maintained cell cultures to accurately determine cell viability and density to support the characterization of master and working cell banks. Optimized protein concentration quantification method to enable assessment of multiple sample matrices. Proficient in analytical ultracentrifugation for determination of empty and full AAV (adeno-associated viral) particles. Isolated DNA from human biospecimens to conduct viral vector shedding analysis by qPCR. Authored method qualification protocols and reports to support regulatory submissions for gene and cell therapies.

Cleveland/Akron, Ohio Area

Managed and led bioanalytical studies including, method development, method qualification, method validation, and non-clinical and clinical sample analysis. Directed and trained scientists on the best practices of instrumentation, wet lab conduct, extraction procedures, and GLP documentation. Generated regulatory and non-regulatory protocols, amendments, study plans, test methods, and reports for client specific proposals. Regularly communicate with the client or client representative to ensure accurate study objectives and provide troubleshooting as needed. Coordinated with other Operational and Quality departments to improve efficiency, quality and communication and resolved site and study specific audits in a timely manner. Drafted, reviewed, and updated site wide standard operating procedures to improve efficiency and meet growing regulatory expectations.

Developed and performed a variety of environmental studies including, sample analysis, residue, method validation, characterization, physical property, fumigation, storage stability, environmental fate. Maintained the greenhouse, the laboratory, and a variety of instrumentation for inspection and performance. Constructed study specific equipment using common hand tools and materials to meet study specific goals. Managed multiple study specific timelines to meet client and site-specific deadlines. Wrote and reviewed regulatory protocols, amendments, certificates of analysis, and reports for client specific proposals.

Bedford Heights, Oh

Performed environmental sampling including, non-viable particulate, water, clean steam, and nitrogen gas line sampling. Completed daily time-sensitive test sessions using aseptic technique and Class 100 monitoring procedures for performance and repair of HEPA filter systems. Monitored and managed sterile core temperature and humidity monitoring systems. Cross-trained and supported microbiological testing. Collected and performed endotoxin and bioburden testing.

Bachelor Of Science - Bs, Biology, General

Education record