Lisa Jeffers

I started my career in the lab, cloning recombinant DNA, transfecting antibodies into mammalian cells, running ELISA assays, conducting flow analysis, performing experiments on mice, you name it. I had a wide range of opportunities over a span of seven years that gave me experience with virtually every stage of the monoclonal antibody drug discovery process. As the company evolved, so did I. As we moved our first product into development towards clinical trials, I discovered a strong desire to learn about Regulatory Affairs, Quality Assurance, Chemistry Manufacturing Controls (CMC), and the other aspects of Product Development. So, in 2010 I took the leap and started down my new path in the Regulatory Affairs and Quality Systems Department. In this time, I have gained experience with, again, virtually every piece of the puzzle. I have experience with stability program management for monoclonal antibody bulk drug substance and drug product, including trends analysis and generation of summary reports; Electronic Document Management System (EDMS) and Quality Records Management System design, configuration, implementation, validation and maintenance; sitting on cross-functional teams that developed and implemented FDA cGMP/GLP/GCP-compliant processes; eCTD format for IND application submissions; internal and external auditing; clinicaltrials.gov listings - initial submission and maintenance of ongoing clinical programs; change control; event reporting; employee training; SOP authoring, and more! In 2013 I started a new opportunity at a larger, more mature biopharmaceutical company. My current focus is on annual Product Quality Reviews for our commercial products. I am incredibly grateful for the wide range of opportunities I have been given. I am constantly learning and evolving, and I look forward to each day as an opportunity to have an impact on the development of potentially life-saving therapeutic products.