Aaron Mc Lain
About Aaron Mc Lain
Aaron McLain is a Principal Scientist currently working at Aimmune Therapeutics, with a background in analytical science and drug development. He has held various positions at Nektar Therapeutics and has a Ph.D. in Biochemistry from the University of Oklahoma Health Sciences Center.
Current Role at Aimmune Therapeutics
Aaron Mc Lain serves as a Principal Scientist at Aimmune Therapeutics, a position he has held since 2022. In this role, he is responsible for providing analytical subject matter expert support for quality control and quality assurance teams. He also supports analytical and manufacturing investigations, ensuring compliance with industry standards. His responsibilities include defining and justifying phase-appropriate clinical specifications for drug substances, drug products, and placebos, focusing on patient safety and product quality.
Previous Experience at Nektar Therapeutics
Prior to his current position, Aaron Mc Lain worked at Nektar Therapeutics in various roles from 2016 to 2022. He began as a Scientist and progressed to Scientist II, and then Senior Scientist. During his tenure, he served as the analytical lead for the Palforzia Life Cycle Management activities and the CDX-6114 Phase 1 development program. His work involved managing routine non-GMP analytical testing and collaborating with quality control teams.
Educational Background
Aaron Mc Lain earned his Doctor of Philosophy (Ph.D.) in Biochemistry from the University of Oklahoma Health Sciences Center, where he studied from 2007 to 2013. He also holds a Bachelor of Science (BS) in Biochemistry, Cell and Molecular Biology from Oklahoma State University, which he completed from 2003 to 2007. His educational background provides a strong foundation for his work in analytical development and quality assurance.
Analytical Expertise and Contributions
In his professional capacity, Aaron Mc Lain drives the selection and management of external analytical laboratories, overseeing processes such as RFP submissions and SOW reviews. He provides expert guidance for method development, transfer, validation, and biophysical characterization activities at CMO/CRO sites. His role also includes designing and executing analytical characterization and comparability studies to support regulatory submissions.
Postdoctoral Experience
Aaron Mc Lain's postdoctoral experience includes a position as a Postdoctoral Associate at the University at Buffalo from 2013 to 2015. He also served as a Temporary Postdoctoral Associate at the Oklahoma Medical Research Foundation for four months in 2013. This experience contributed to his analytical skills and expertise in biochemistry, further enhancing his qualifications in the pharmaceutical industry.