Thermal, tensile, rheological and physical property testing of plastics, polymers and novel materials to ASTM and ISO standards required for product development, CAE and R&D in a ISO17025 and A2LA accredited test laboratory. In charge of maintaining and upgrading more than 100 test frames in the proprietary CREEP laboratory and overseeing calibration and verification of various lab equipment per A2LA and ISO requirements. Selected to be an in-house auditor.

Quality control testing of raw materials used in pharmaceuticals to BMS, USP/NF, EP and JP standards. Prepared reagents, samples and solutions, performed analysis per SOPs and specialized methods, data entry and data review in cGMP, cGLP lab. Active in root cause analysis, investigations and safety matters. Trained staff and active in other projects.

Performance testing of cell cultures, feed supplements and media for pharma and biological research. Coordinated experimental design and analysis, scheduling, purchasing, daily logistics, equipment maintenance and relocation of laboratory equipment to Wisconsin.

Performed chemical permeations, penetrations and specialized testing per ASTM, NFPA, ISO and other standards. Ordered chemicals and supplies when needed.Created time and cost-saving chemical inventory database of over 400 chemicals used in the lab, including chemical waste disposal. Updated MSDS and maintained safety equipment.Doubled capacity of testing chamber by making approved modifications to setup, resulting in time savings and increased revenue from chamber while also increasing safety. Improved communication with clients and coworkers by writing reports and updates with clarity and concise detail. Trained coworkers on new test methodologies and standards.Factory-trained on new instrument software, enabling increased productivity, then taught the methods to coworkers and lab supervisor. Troubleshot systems when needed.

Prepared buffers, reagents and samples for flow cytometry lab of bovine sexed semen artificial insemination product. Suggested improvements in process and workflow.Performed literature searches and experiments for process improvements. Helped production team revise SOPs with input from corporate technology team.Centrifuged, pooled and cryopreserved sorted samples. Frequent use of biological lab equipment, including filters, microscopes, LIMS, pipettes, pH meters, autoclave and scales. Performed IVOS QC analysis on product and recorded results on Excel spreadsheet.Active participant in Safety Team, QC and Process Optimization.

Led pilot team to design experiments and equipment to test and scale up sterile plant cell cultures from shake flask scale to 1000 liter stirred tank bioreactors. Produced paclitaxel under contract for major pharmaceutical company.Scheduled and supervised five technicians and operators in maintenance of bioreactors, sterile plant cell cultures, and the process equipment associated with them. Ensured that all pilot plant operations were compliant with established procedures (FDA/GLP/GMP) and all reports, batch records and data entry were accurate and complete. Wrote, revised and enforced SOPs and safety protocol. Trained and mentored technicians.Supervised ongoing process improvements. Developed and managed pilot plant budget and forecasts. Projected production scenarios and tank plans using Microsoft Project and Excel.Successfully met aggressive production targets and converted pilot plant from R&D operation to small-scale production facility despite 33% reduction in pilot plant manpower. Redesigned and ordered parts to fabricate two new 1000 liter bioreactors. Represented pilot plant at meetings. Provided support for R&D and large-scale production operations in Germany. Helped troubleshoot production and sterility issues.Active on committee to interview, hire and train new personnel for relocation; Helped train new directors, managers, scientists and technicians in pilot procedures. Assisted architects on blueprints and executed an exit plan to transition to new facility.

Scaled up production of sterile plant cell cultures for pharmaceutical metabolites through process improvements, redesigning equipment and ongoing experiments in pilot plant.Maintained cell cultures & processed samples. Repaired, installed and calibrated equipment. Authored SOPs, experiments and production timelines. Trained new technicians. Took lead role in cell transfers, inoculations, tank plans & reactor checks. On call after hours.