Canada
As a Scientist and Research Professional with over 5 years of experience in manufacturing and R&D environments, I have a proven track record of successfully leading and executing scientific projects from conception to completion. I specialize in using my technical expertise to optimize manufacturing processes and develop innovative solutions to complex research problems. My skills in project management, GMP, Lean Six Sigma green belt, data analysis, and collaboration enable me to work effectively in cross-functional teams and deliver high-quality results. I am passionate about advancing science and technology and I am always seeking new opportunities to grow and learn in my field.
● Manufactured 250+ medical diagnostic kits (approved by Health Canada and FDA) by adhering to Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOPs). ● Performed FMEA, nonconformance investigations, CAPA, and wrote deviation reports which ultimately helped resolve customer complaints on time. ● Updated and reviewed SOPs, work instructions, Specifications, Device History File (DHF), and Device Master Record (DMR) to align all documents with MDSAP and ISO 13485 regulations. ● Successfully installed and qualified (IQ, OQ, PQ) manufacturing equipment including Scienion Microarray Printers which increased production capability by 50% ● Led process improvement measures that saved over $3000 in monthly expense. ● Developed a project management system with ASANA and Microsoft Excel to outline project requirements needed for improvements, schedule project activities, and delegate workflow to staff. This facilitated team wide communication and timely project completion.
● Successfully analyzed the effect of antibiotics on bacteria isolated from sputum of cystic fibrosis patients using cell culture and confocal laser scanning microscopy techniques. ● Developed ELISA and dot blot assays to measure the amount of polysaccharides on the surface of bacteria cells. ● Compiled and interpreted research data that led to 2 research publications.
● Performed PCR and DNA cloning experiments for research projects that studied the structure and function of mitochondrial membrane proteins. ● Analyzed purified recombinant proteins using SDS-PAGE, Western blot, Bradford and Lowry assays, circular dichroism (CD) and fluorescence spectroscopy. ● Taught new students on effective use of laboratory equipment and techniques including DNA cloning, cell culture, protein purification, UV-Vis and fluorescence spectrophotometers, microplate reader, DynaPro dynamic light scattering (DLS), nanodrop, and incubators.
● Instructed 20 – 30 students in organic and biochemistry laboratories on the effective use of experimental equipment while following Good Laboratory Practice (GLPs). ● Educated students on scientific principles and techniques to provide a deeper understanding of each laboratory exercise. ● Marked laboratory reports with detailed attention and provided students with comments that improved their scientific report writing skills.
● Prepared informed consent forms (ICFs) in accordance to good documentation practices (GDPs), good clinical practices (GCPs), and standard operating procedures (SOPs). ● Reviewed and finalized clinical study reports (CSRs) in accordance with Health Canada and FDA regulations.