email@example.com 316-***-**** 336 Charlie Court, Apartment 3D, Portage, MI 49002 SUMMARY
• Researcher within the pharmacological field working in a pre-clinical and early clinical drug research, focused on Biomarkers, small and large molecules, Ligand-binding assays, and RNA assay. EDUCATION
• ELISA, electrochemiluminescence, and fluorescence immunoassay Experiments
• Dev elop, and v alidate Bioanalytical, RNA, Cell and ligand- binding assay methods for clinical and non-clinical studies.
• Separation/purification techniques of proteins/analytes.
• PPE, SPE, and SLE extractions of Small molecules.
• Quantitative Bioanalytical data analysis.
• Laboratory safety
• Instrument maintenance and calibration
• Organizational skills
• Instrument maintenance and inv entory management of supplies and prep of lab materials and stock solutions.
• Detail Oriented and experienced with Clinical Chemistry and Pathology.
• Report writing
• Interpersonal and written communication
• Project management
• LC-MS/MS, UPLC, and spectrophotometers.
• Cell/Tissue/Bacteria Cultures experiments and aseptic technique.
• Branched DNA/RNA experiments and problem solving.
• Data management through Excel, Watson (Pilot,
Production, and IRM), and LIMS.
May 2018 - Current
• Validation support for multiple projects, including protocol and report development, data v erification, deviation and change control assessments.
• Lead re-v alidation projects and responsible for Clean Equipment Hold Time study
• Establish an Upper Blend Time for Micronized Products study.
• Create and update cleaning validation protocols, reports and records.
• Organize required audit documentation for cleaning and process v alidation.
• Actively participate with auditors during multi-customer audits.
• Ev aluate and summarize all process v alidation activities performed in Annual Product Record Rev iews (APRRs).
• Dev elop Qualified Equipment Periodic Review Reports for several units.
• Updating documents, cleaning procedures, and SOP work. Nov 2016 - Jan 2018
Dept of Bioanalytics
• Pioneered as first RA cross functionally trained in three different critical branches of research.
• Analyzed test article samples to determine pharmacokinetic and anti-drug antibody profiles in matrices to meet or precede pass rates of 95%.
• Performed quantitative sample analysis to determine RNA binding efficiency of specific gene targeting drugs
• Analyzed nucleotides, peptides and steroid samples using LC/MS
• Worked with method development scientists to efficiently adapt and v alidate bioanalytical and Ligand-binding assay methods
• Assisted with process improvements, such as creating and implementing new documentation design for pharmacokinetic assays
• Increased wet lab work efficiency through documented data and experimental design for GLP standard lab work.
Bachelor of Science: Biochemistry
PITTSBURG STATE UNIVERSITY.
• Minored in Biology
• Conducted research on gene expression of hnRNP C, hRaly and hRalyl proteins associated with pre-mRNA processing and subsequent v ector insertion into E. Coli plasmid.