Aaron Pyle Email & Phone Number

York, Pennsylvania Area

o Extensive experience in Microtrac’s Good Laboratory Practice (GLP) working with SOPs, reference materials, instrument validations and storage records.o Proficiency of Laser Diffraction, Dynamic Light Scattering (DLS), zeta potential and 3D imaging instrumentationo Work closely with sales teams and customers to interpret and problem solve customer needs related to quality control, process improvement, data interpretation & material research.o Create and provide on time delivery of extensive laboratory reports with in depth analysis of particle size distribution, zeta potential and imaging data (examples furnished upon request)

Baltimore, Maryland Area

• Pharmaceutical Regulatory Courses: Introduction to Regulatory Affairs, Regulatory Strategies in Biopharmaceuticalso Focus on strategically managing FDA regulatory pathways to facilitate approval of a drug or drug device with optimum speed, cost and accuracy. Employed techniques: Accelerated Approval Pathways, orphan drug approval, de novo. Additional focus on the clinical process, drug approval lifecycle, tenets of GXP (GLP, GCP, GMP), ICH CTD/eCTD, INDs, CMCs, NDAs, BLAs, MAAs, etc.o Final project paper: “Direct to Consumer Advertising” as related to regulatory strategy.o Case study: “Belantamab Mafodotin: Case Study on Regulatory Strategies”. This project featured the accelerated approval pathway and consideration of its surrogate endpoints.• Business Courses: Project Management & Finance for Biotechnology, Technology Transfer & Commercializationo Simulated a coffee shop renovation project using Project Management tools including Work Breakdown Structures, budget and actual cost evaluation, project schedule analysis and RACI charts.o The process of developing a product from R&D to the marketplace with a strong focus on assessing a technology for its viability. • Technical Courses: Introduction to Bioinformaticso Direct experience with genetic sequence databases (ENTREZ, Ensembl, BLAST, Clustal Omega Ω) to identify and analyze similarities and differences for genomes, genes, ESTs, proteins and other genetic components.o Global team project focused on analysis of a previously unresearched gene including assessment of similar genes across different species, the gene’s corresponding mRNA, protein sequences, and its phylogeny. Our unknown Gene, associated protein DUF559, was collaboratively researched by group members in different time zones.• General Courses: Molecular Biology, Biochemistry, Advanced Cellular Biology, Genetics, Human Anatomy, Immunology, Organic Chemistry, Instrumental Analytical Chemistry, Biostatistics

York, Pennsylvania Area

o Communicate with doctors and nurses to report critical values of laboratory findings of various patient sampleso Phlebotomy experienceo Laboratory experience in processing specimens for Chemistry, Hematology, and Microbiology departments.

Master Of Science - Ms, Biotechnology

Pharmaceutical Regulatory Courses: Introduction to Regulatory Affairs, Regulatory Strategies in Biopharmaceuticals Business Courses.

Bachelor Of Science - Bs, Clinical Laboratory Science/Medical Technology/Technologist

General Courses: Molecular Biology, Biochemistry, Advanced Cellular Biology, Genetics, Human Anatomy, Immunology, Organic Chemistry.

Master'S Degree, Biotechnology