Navya Arigapudi Email & Phone Number

Grove City, Oh, Us

Grove City, Oh, Us

• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to manufacture gene therapies for rare disease clinical trials • Successfully executed upstream engineering and GMP runs at 50 L, 500 L, and 1000 L scales, including critical tasks: mammalian cell culture, transfection, and depth filtration, while adhering to cleanroom protocols• Collaborate with teams of 3-5 colleagues to complete processes, including prioritization of changing responsibilities, documentation, and interdepartmental communication• Use Excel to analyze cell culture and bioreactor data; communicate trends to leadership for future steps• Create summary reports for each process to convey critical data with context to clients• Critically evaluate process deviations, optimizations, and implementations adherent to GMP• Write thorough, concise standard operating procedures (SOPs), work instructions (WIs), and master production records (MPRs) for operations• Mentor and train interns to support their introduction to GMP and process flows• Coordinate with Quality teams, Process Development, and Supply Chain to ensure efficient process flow

Columbus, Ohio, United States

Columbus, Ohio, United States

• Maintained seed train for three months using aseptic technique; took Vi-cell data to evaluate cell viability• Performed downstream purification process four times: ran samples on Akta pure, pulled empty and full bands after ultracentrifugation, dialyzed full bands• Updated Benchling platform data; created five practice client presentations including discussion of results

Cleveland, Ohio, United States

• Learned about GMP and FDA regulations, quality management, release testing, and environmental monitoring for cell culture and manufacturing• Collaborated with regulatory specialists to understand the timeline and requirements for submitting regulatory documents, including CAPA documentation, to an IRB, the FDA, and the ICH• Followed protocols to regularly run BCA assays to practice quantifying the amount of protein in a sample• Observed cell culture techniques and conducted media changes with two cell lines in a sterile environment• Attended weekly meetings with PIs to discuss the applications of their stem cell research projects• Received training for laboratory safety and biosafety

Cleveland, Ohio, United States

Ann Arbor, Michigan, United States

Ann Arbor, Michigan, United States

• Investigated amount of blood drawn for research versus clinical purposes from pediatric patients enrolled in clinical trials• Created a REDCap database to input patient information and calculate total amounts of blood• Reviewed MiChart data within a one-year time period to gather data about blood draws for various tests • Collaborated with team members to submit and receive approval for an IRB application

Pellston, Michigan, United States

• Studied effect of zebra mussels, an invasive species, on native clam populations in five lakes• Utilized R software to analyze statistical trends in clam health• Worked alongside five student researchers to identify data trends and develop a presentation to convey findings• Co-authored a paper available to all University of Michigan students and faculty via Deep Blue Database

Ann Arbor, Michigan, United States

• Investigated ability of cells to self-organize and arrange their contents for proper function• Determined facets of optimal procedure to make microdroplets filled with cytoplasm for lab use• Analyzed microdroplet images using a stereoscope to understand how differences in procedure affect microdroplet size and shape• Monitored water quality of 15 tanks to ensure optimal environment for zebrafish • Wrote weekly lab reports to share experiment results and outline further tests to collect data for analysis

Ann Arbor, Michigan, United States

Master'S Degree, Applied Anatomy

Activities and Societies: Forge Forward

Bachelor Of Science - Bs, Biology, General

Activities and Societies: Books for a Benefit Red Cross Club Biological Station Mott's Children’s Clinical Trials Support Unit Biophysics.

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