Greg Lobdell Email and Phone Number

Led utilities & single-use equipment commissioning and validation in a small and large team environments●Performed utility system URS revision, TOP generation, commissioning/validation protocol generation, execution, and report generation●Utility systems commissioned and validated include plant steam, glycol, HVAC AC, HVAC chilled water, process chilled water, CO2, WFI, O2, instrument/process air, and purified water with P&ID walk-downs and vendor turnover package review●Performed equipment validation protocol installation verification and functional testing execution for single-use cleanroom equipment●Equipment validated include an autoclave, parts washer, single-use mixing vessels, bioreactors, and chromatography columns

Led equipment commissioning, equipment & process validation, and project management activities for sterile manufacturing of eye drop products.●Led validation & SOP project planning for the client site●Led Site Acceptance Tests (SAT) and IQ/OQ/PQ for sterile filling equipment●Wrote process validations for sterile eye drops from compounding through packaging of final product●Wrote IQ/OQ/PQ for automated packaging equipment●Assisted in understanding and fulfilling the client's staffing needs and frequently refers candidates●Led process improvements to fulfill the client's technical needs●Participated in the development of internal training webinars for PSC employees●Able to provide the client with efficient validation protocols and reports which consistently meet validation requirements while easily integrating into the client's quality system●Consistently met deadlines while optionally working up to 40% remotely on a weekly basis●Able to work independently on projects while also working effectively with project teams

Managed product line changes, process improvements, process qualifications, equipment validations, and two validation engineers. ●Led the transfer and associated validations of two major product areas to the new facility●Technical owner for multiple product lines●Led product defect investigations, process improvements/changes, process qualifications, and equipment validations (IQ/OQ/PQ) including large scale automation●Developed, marketed, implemented, and owns the daily equipment induction process●Managed multiple individual contributor team members & reviews work from peers and junior staff ●Developed strategy of equipment move plan and helped create schedule for site relocation ●Led material qualifications, risk assessments, deviation requests, and re-works●Participated in Practical Process Improvement (PPI) business systems, lean lite, and value stream mapping●Worked cross-functionally with manufacturing, R&D, marketing, project management, supply chain, and quality●Knowledge in 21CFR Part 11 guidance, ISO standards, Quality Engineering statistical analysis using Minitab, Microsoft Office, SAP, and asset management software (BlueMountain)

Developed immunoassays, performed validations, and tested samples for GMP and GLP client driven studies● Direct experience with clients as the principal investigator for bioanalytical studies● Validated GMP Release assays and performed sample testing● Validated immunoassay plate washer and MSD plate reader equipment● Conducted Out of Tolerance (OOT) investigations and deviation reports● Experience with PK assay development and sample testing ● Working knowledge of Watson LIMS, Labvantage Sapphire, and GraphPad Prism

Developed and qualified quantitative ligand binding assays utilizing various platforms to support biomarker, PK, and toxicity pre­clinical studies in a number of different species● Developed, qualified, and completed sample testing for many assays supporting PK, biomarker, and exploratory toxicity studies in different species including monkeys, rats, and mice● Performed PK analysis to support ADME functions● Supported studies for therapeutics in areas such as obesity, autoimmune diseases, and painreduction● Immunoassay experience using various platforms, including automation, such as GyroLab, Octet,MSD, ELISA, and Singulex bead coupling● Helped develop high­throughput immunoassay processes utilizing automation, such as HamiltonStarlet liquid handling, and via 384­-well MSD method development● Experience using ligand binding assay software such as Design of Experiments, Watson LIMS,SoftMax Pro, GraphPad Prism, and well versed in electronic notebook keeping & peer­-reviewing(IDBS E­Workbook)● Experience in collaborating with vendors and using their emerging innovative assay technologiesfor in­house assay development projects and experience in selecting appropriate commercialantibodies from vendors● Presented data at large PDM departmental meetings and innovative technology meetings● Frequently summarized data, communicated with project representatives, wrote job aids, andorganized & lead group trainings & meetings

Screened, purified, and QC’d antibodies to support Prostate Cancer biomarker immunoassay development. In addition, contributed to immunoassay development for Prostate Cancer biomarkers & Diabetes early-stage therapeutics and characterized acquired biomarker proteins. ● ELISA development experience for Prostate Cancer biomarkers & Diabetes early-stage therapeutics in serum and cell lysate utilizing many ELISA formats● Immunoprecipitation assay development for Prostate Cancer biomarkers ● Screened & characterized antibodies from hybridoma clones for binding specificity, cross-reactivity, and isotype using techniques including western blotting, ELISA, and lateral flow assays● Purified antibodies using FPLC and QC’d antibodies to be used in the biomarker assay development using techniques including western blotting, ELISA, & BCA assays ● Proficient in protein characterization for newly acquired biomarker protein in preparation for LC-MS using techniques such as western blotting, in-gel digest, and BCA assays● Collaborated and arranged meetings with colleagues & managers from multiple groups● Trained Research Associates & assumed the lead role on multiple projects● Wrote scientific reports and presented data at departmental meetings● Responsible for purchasing equipment, ordering items for the immunoassay lab, and shipping/receiving ● Responsible for editing protocols & maintaining the FPLC, ELISA plate washer, and -80C freezer

Perform molecular diagnostic testing on research laboratory animals for both viral, RNA and DNA, and bacterial agents to support and accelerate drug development through laboratory research animal models● Frequently extract DNA and RNA from various sample types including, but not limited to many different tissue types, cells, proteins, and swabs● Perform real-time PCR on extracted DNA via Applied Biosystems’ TaqMan system on 384 & 96-well platforms● Perform real-time DNA microarrays on extracted samples requiring numerous assays to be screened● Skillfully analyze PCR & microarray results and establish & carry out appropriate re-testing procedures● Accurately report results to the appropriate sponsors and customers via ILIMS software● Contributed to the R&D Reovirus time-course study

● Successfully purified protein from stable mammalian cell line for influenza research● Developed stable mammalian cell line for long-term production of protein for oncology research● Contributed to quick high-throughput expression validation via transient expression with PCR products using western blotting techniques● Performed daily maintenance of mammalian cell line

● Tested QC release protocols in cation exchange resins● Performed ELISAs to test resins for Protein A leakage and CHO HCP contamination levels● Tested resin properties for binding capacity, selectivity, and size● Developed method for 96-well plate chromatography assay● Developed Malvern Mastersizer experimental protocol to measure particle size