Kristen Boles

Extensive Experience managing personnel, prioritizing resources, conducting lab investigations and reviewing testing to ensure lot release and stability timelines are met in an efficient and compliant manner: - Aligns departmental priorities with available resources within my testing group - Implemented a recurring team meeting to promote knowledge sharing and personnel development Actively involved in Continuous Improvement initiatives: - Completed Six Sigma Green Belt certification and lead Green Belt project targeted at improving transparency, efficiency and predictability of on-site testing and release of product lots Responsible for review and approval of a range of lot release and stability assays including Cellular Uptake, Activity, ELISA, Osmo, pH, dissolution, content uniformity, RP-HPLC, SEC, SAX and CGE Extensive experience conducting laboratory investigations, deviation write-ups, root-cause analyses and CAPA determinations: -Working knowledge of 21CFR, USP, EP, JP, and ICH regulatory guidelines associated with the testing and investigation of biologics and small molecule assays - Familiar with validation and verification requirements for methods run in a GXP environment Managed testing and reporting of three clinical product lines to ensure filing deadlines were met and stock was available to clinics: - Acted as the CMC representative for the QC group for one of the three product lines - Provided data for filings and IND updates and worked closely with the Regulatory team

Extensive Experience Manufacturing, Troubleshooting, and QC testing 384 well and 96 well Real-time HLA Assays • Managed large build manufacturing projects through production, troubleshooting, and quality control testing phases  Effectively managed available personnel and coordinated efficient instrument usage  Created and managed necessary paperwork and ensured its proper completion for QA sign-off  Designed complex pre-production trouble-shooting experiments, generated and analyzed Melt Curve data, and determined next steps  Assessed DNA sample levels and made necessary dilutions from stocks of varying concentrations  Tested Manufactured Assay Plates prior to release • Extensive experience running A7900, LC480, and VIIA7 Real-time PCR instruments • Extensive experience running operating Hamilton MicroLab Star, Hydra, and BioMicroLab XL Tubesorter to perform daily tasks  Wrote and ran BioMicroLab XL sorting files on a daily basis. Expert in troubleshooting and error handling techniques  Proficient with creating worklists, running methods, error handling, and proper maintenance techniques on the Hamilton MicroLab Star instrument  Expert in manufacturing both 96 well and 384 well PCR plates on the Hydra instrument • Managed 50uM primer stock inventory for manufacturing builds and troubleshooting experiments • Trained new personnel on Manufacturing and QC procedures

Managed Y-Chromosomal STR PCR Assay Development for FBI Contract Led validation testing for assay Collected and organized mass spec data analyses for Quarterly reports Attended 2011 American Society of Mass Spectrometry (ASMS) Convention as a poster presenter for Y-STR Assay Led problem-solving and optimization efforts- Improved PCR cycles, identified inefficient primer pairs, etc. In charge of transferring assay from development to manufacturing Extensively involved in Euro STR Assay Development Developed and tested primers and multiplexes Preformed studies on abnormally behaving alleles using bacterial transformation, extraction, isolation and purfication techniques

Implemented and improved product testing procedures, managed department’s Time of Flight Mass Spectrometer, and worked on developmental projects to increase mass spec efficiency Worked in BSL2 environment setting PCR reactions with sterile and aseptic techniques Manufactured buffers, reagents, and assay plates in Class 1000 clean room Trained numerous personnel in various manufacturing and QC roles Developed and Documented key Manufacturing Procedures Involved in transfer of new products from R&D to Manufacturing Helped document batch records for new assay plates (HAI MRSA, HAI VRE, Sterile Fluids Bacteria and Virus, etc.) and manufactured items (Tuning Solution, Mass Cal plates, BSA, etc.) Helped with documentation of testing procedures and release specifications of new products Tested and determined feasibility of new Magnetic bead formulations. Then found proper dilution to insure peak performance of Mass Spectrophotometer Worked Closely with Materials Management Contributed in planning weekly work loads Assisted in materials management processes when needed Performed shipping duties when needed Responsible for Breadth of Coverage Testing of Bacterial Assay Plates Worked with live and boil prepped E. coli, Salmonella, Listeria, MRSA, VRE, KPC, Pseudomonas, and Shigella Involved in analysis of testing data Managed Manufacturing/ QC Department's Time of Flight Mass Spectrometer Responsible for running Assay Plates and reagents Preformed Spectral Data analysis for Assay plate, reagent, and component QC Extensively involved in trouble shooting and maintenance of instrument Responsible for QC, Data Analysis, and Stability Time points for key Manufactured Product

Responsible for maintenance of a small vaccine development laboratory Experience growing and maintaining bacterial cultures Extensive Spin Prep and DNA purification experience Helped Maintain Human cell line used for vaccine development Worked with mice to create in vivo vaccine models Extensive experience running agarose gel-electrophoresis