• Quality Assurance lead overseeing pharmaceutical clinical and commercial manufacturing.• I am involved in leading process improvement projects, deviation and CAPA management, change control management, executed batch record review and other tasks in an effort to enhance the quality of the product and create a lean manufacturing process at our pilot plant.

• Facility design for GMP and non-GMP laboratories and suites to support gene and cell therapy operations.• Played a key role in establishing departmental goals and creating company culture in an aggressive start-up CDMO atmosphere.• Collaborated with architectural and engineering firms on laboratory design and process and building utilities • Equipment specification and procurement for processing needs• Determined departmental needs and carryout analysis on system processes including purified water requirements, bulk gas consumption, clean steam use, and sterility/clean room requirements to meet GMP specification• Asset enrollment and tracking for site equipment and systems through Blue Mountain (CMMS).

• Support production and increase efficiency through implementation of new procedures, product scale-up, and assay enhancement.• Create protocols, execute studies and prepare final report write ups for various stages of assay development.• Perform data analysis using JMP software, Origin software, Analyse-it, and Microsoft Excel.• Operation of ARCHITECT Immunoassay instruments to support studies.• Completed and on-going projects include: ARCHITECT CYFRA 21-1 Reagent Scale-Up, ARCHITECT Methotrexate REACH Project, ARCHITECT CA 242 Development Project (Discovery Phase), ARCHITECT CA 125 Magnetic Separation Conversion/Product Scale-up (Concept and Discovery).

• Performed antibody-enzyme conjugations and biotinylations, purification of conjugates involving FPLC, and other various assays in the production of in vitro diagnostics and biomarkers. • Processed aseptically in soft-wall for bulking and filtration of products.• Use of GE Äkta Avants and Explorer for FPLC analysis.• Manufacturing and ordering of reagents for processing needs.

Biotechnician for VAQTAo Upstream and Downstream processing of the hepatitis A vaccineo Bioreactor assembly, data recording and monitoringBiotechnician for RotaTeqo Manufactured the vaccine RotaTeq (pentavalent rotavirus vaccine) in aseptic clean-room environmento Performed clean room practices for vaccine production; including aseptic technique, sterile welding, biosafety cabinet and laminar flow hood use, aseptic gowning, cleaning and disinfecting procedures, SOP adherence, and full knowledge of cGMP regulations.o Executed various biological procedures; including cell counting by hemocytometer, weighing and dispensing of media and product, pipetting, and centrifuging.o Performed environmental monitoring tests and collected data to uphold GMP compliance.o Proficient in multiple processing systems, including HANDEL, SAP, PAS-X, BACH and LIMS.o Approved SOP Author. Experience in training technicians on new and updated processes.o Safety Committee Leado Validation experience; SAT, IC, OC, IQ, PQ of various equipment and processes

Quality control for chemical manufacturing of sodium borohydride and related products: • Performed quality control assays on samples including acid/base titrations, gas chromatography, distillation, hydrogen evolution. • Environmental reporting (SARA and TIER II)• Hazardous chemical shipping professional. DOT trained for shipping dangerous goods. EPA, OSHA and PA-DEP trained in safety and environment. Hazwoper trained in chemical plant safety for emergencies. • Manager of the lab (2009) until departure from the company in June.