Medical Device Document Control

Lisa Circle

**** ***** ****, ****, ** *****

937-***-**** • *********@*****.***

www.linkedin.com/in/lisa-circle-32175711

Objective:

A Laboratory Supervisor role where my extensive experience will enable me to improve quality, safety, performance, and compliance, as I have done throughout my career.

Summary:

Proven record of achievement supervising laboratory personnel and managing laboratory operations. Comprehensive background in the use, maintenance, and troubleshooting of microscopes, centrifuges, incubators, particle counters, micropipettors, biological safety cabinets, and other laboratory equipment. Highly familiar with medical device development, FDA guidelines, project management, research, document control, and procedural development. Completed cGLPs, cGMPs, blood borne pathogen, and quality system implementation training. Previously supervised teams of laboratory technicians and oversaw multiple research projects simultaneously. Career highlights include developing a program for isolating and maintaining porcine hepatocytes in culture, creating guidelines for implanting porcine islet macrobeads in humans, and a method of testing cells for drug clearing ability in culture. Excellent problem solving, communication, and mentoring skills.

Professional Experience:

The Rogosin Institute, Xenia, OH, 2000 – 2020

R&D Supervisor III (2011-2020)

R&D Supervisor II (2008-2011)

Diabetes Research Technician (2000-2008)

Promoted from a technician role to a supervisory position at this organization specializing in cancer, diabetes, and kidney disease. Supervised 5 research technicians and 2 interns across 2 facilities.

Developed, tested, and executed new techniques for porcine islet isolation and islet encapsulation in a medical device that secretes insulin for control of diabetes in humans.

Designed, edited, and approved standard operating procedures (SOPs) and laboratory policies.

Responsible for the maintenance and support of laboratory equipment, management of projects, and performance of technicians. Maintained a Class 5 cleanroom, experimental laboratory, and support facilities.

Ensured compliance with Good Laboratory Practices (cGLPs) and CFR 21, conducted equipment, safety, and compliance training, monitored spending vs. budgets, procured supplies, and oversaw quality control functions.

Conducted research on porcine pancreas, including the Islet of Langerhans, and the insulin production pathway.

Selected Accomplishments:

Conceptualized and implemented the porcine hepatocyte program and formulated all guidelines.

Developed and tested a successful method for isolating and culturing porcine hepatocytes to facilitate the design of an assay to test drug clearance in vitro. Created the guidelines for implanting porcine islet macrobeads in humans.

Ensured compliance with FDA, Center for Biologics Evaluation & Research, and US Dept. of Health & Human Services guidelines for xenotransplantation and assay development.

Increased total islet yield from a single porcine pancreas more than 15x, resulting in dramatic cost savings.

Co-authored journal articles regarding the isolation, culture, and optimization of agarose-encapsulated porcine islets.

Produced a highly cost-effective method of developing spheroids from hepatocyte cells and cell clusters, resulting in an extended length of time for phenotype viability in culture.

Adapted 2 assays to use a routing methods for testing spheroid drug clearing capability and ammonia conversion to urea.

Enhanced laboratory efficiency by cross-training technicians on ELISA performance and histological preparation.

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Lisa Circle • Page 2

Education:

BS with emphasis in Biology, Urbana University, Urbana, OH

Technical Skills:

Laboratory: ELISA, Spectrophotometers, Particle Counters, CO2 Incubators, Microscopes (compound, inverted, fluorescent, dissecting), Biological Safety Cabinets, Laminar Flow Hoods, Fume Hoods, Centrifuges, Balances, Fyrite Meters, Heat Blocks, Steam Autoclaves, Refrigerators (-80oC, -20oC), Micropipettors, Water Circulators, Hemocytometers, Waterbaths, Dessicators, Rocking Platforms, Shakers, Washers, Orbital Shakers

Computers: MS Office, Access, various laboratory databases and systems

Publications:

Holdcraft RW, Green ML, Breite AG, Circle L, Meyer ED, Adkins H, Harbeck SG, Smith BH, Gazda LS; “Optimizing porcine islet isolation to markedly reduce enzyme consumption without sacrificing islet yield or function.” Transplantation Direct, 2(7), e86 (2016).

Holdcraft RW, Gazda LS, Circle L, Adkins H, Harbeck SG, Meyer ED, Bautista MA, Martis PC, Laramore MA, Vinerean HV, Hall RD, Smith BH; “Enhancement of in vitro and in vivo function of agarose-encapsulated porcine islets by changes in the islet microenvironment.” Cell Transplantation, 23(8), 929-944 (2014).

Gazda, LS, Adkins H, Bailie JA, Byrd W, Circle L, Conn B, Diehl CH, Hall RD, Rubin AL, Smith BH; “The use of pancreas biopsy scoring provides reliable porcine islet yields while encapsulation permits the determination of microbiological safety.” Cell Transplantation, 14(7), 427-439 (2005).

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