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My Journey from the Lab, to Small Biotech, to Big Pharma

by: Monique Carter As an American Chemical Society scholarship recipient, my college extracurricular activity schedule typically revolved around the availability of the department mass spectrometer and my lab mentor. Following completion of my degree in biochemistry and physics, I believed without a shadow of a doubt that I was prepared to take on any task required to become one of the greatest scientists of all time. There was no way that I could have even scarcely fathomed the idea of my name not being mentioned among the likes of Marie Maynard Daly, Marie Curie, and Rosalind Franklin. My overwhelming (naively) optimistic enthusiasm was dulled significantly when I transitioned to a larger research institution and solely focused my attention on laboratory work. Said dulling was greatly emphasized on a daily basis as I visually scanned a countless number of GFP-tagged C. elegans ventral cord neurons through a microscope in a dark room with nothing but National Public Radio (NPR) to keep me company. My discontentment was not a direct result of watching the little transparent creatures swirl around in their double-stranded RNA laced food, but instead stemmed from the fact that I longed for the opportunity to be involved in research that was closer to achieving advances in health care. I wanted a dynamic career where I could be involved in multi-disciplinary teams that focused on the movement of interesting basic science into novel clinical application. After an extensive amount of research about different science-based career opportunities, I was particularly intrigued by the drug development lifecycle. My interest was piqued after completing an internship at a boutique oncology consulting firm where I had the opportunity to deeply understand the many processes involved in the life cycle of a targeted therapy. After my internship, I was offered a full time position as a research analyst and accepted. Over the course of a 2.5 year period I was promoted to project manager, then senior associate, and before leaving the company I was the sole manager and senior consultant of the strategic consulting department. The greatest thing that I gained from my first non-laboratory based position was how the drug development process works and the many different functions involved. I then transitioned into a senior scientist and translational research management position at a small biotechnology company housed under an investments firm umbrella. I had the opportunity to be involved in the complete development life cycle of different novel small molecule inhibitors and monoclonal antibodies. I managed the company’s patent portfolio and was responsible for the regulatory development strategy from preclinical through proof-of-concept. I was responsible for writing all patent related documents submitted to the United States Patent and Trademark Office (USPTO) as well as regulatory submissions to the Food and Drug Administration (FDA) and other ex-US regulatory agencies. After approximately 2.5 years in small biotech (a total of 5 years in industry) I had my eyes set on big pharma. To show my knowledge of the drug development process and patent prosecution, I prepared to sit for a number of different qualifying exams, including the United States patent bar and the Regulatory Affairs Professionals (RAPS) Regulatory Affairs Certification (RAC) exam. I recently began working in the Worldwide Regulatory Strategy, Global Innovative Pharma Business Unit at Pfizer, Inc. I really love the environment and have truly put all of the knowledge that I have gained through the Masters of Science in Biotechnology program from Johns Hopkins to work. I am continually blown away by the sheer size of the organization and particularly intrigued by the communication that takes place across all of the different disciplines. It is definitely translational research in action! The countless number of drugs in the company’s pipeline and the room for growth, both educationally and career wise, makes me ecstatic! I am convinced that big pharma was what I longed for while listening to ‘All Things Considered’ on NPR and switching the microscope diaphragm repeatedly to get a better view of the infamous green dots. While the odds of becoming a Nobel Laureate are stacked against me, I wouldn’t change my journey for anything in the world! I am convinced that the hands on experience that I gained in the lab, consulting, and small biotech, as well as the formal education that I received from Johns Hopkins, prepared me for a role in regulatory strategy at Pfizer.  I am excited to see what the future holds in this dynamic space! Please contact me at Monique_J_Carter@hotmail.com to keep the discussion going—I am such a hospitable Texan at heart that if requested to do so, I can speak more about regulatory strategy and even delve into the interesting art of creating a perfect podcast streaming schedule while viewing the many twists and turns of C. elegans on bacteria seeded agar plates!

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