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Aaron-McLain

Aaron McLain, PhD

CMC Consultant

Aaron joined Biologics Consulting in November 2024 and has 10 years of industry experience with a focus on analytical development and quality control for biologics. He has direct experience supporting biologics programs from pre-IND through BLA. His expertise includes analytical development, quality control, protein characterization, stability programs, process development and authoring regulatory submissions. Aaron was most recently Associate Director of Analytical Development at Aurinia Pharma where he led the biologics analytical development team, developed CMC strategy, and authored Module 3 sections and responses to FDA requests. Prior to Aurinia Therapeutics, he worked at Aimmune Therapeutics and Nektar Therapeutics. He was a Principal Scientist at Aimmune and responsible for addressing post-approval analytical and formulation commitments for the company’s peanut allergy drug Palforzia. At Nektar, he was a Senior Scientist with responsibility for: team lead for external analytical testing; method development, transfer and validation; oversight and management of the internal biologics GMP lab; quality records for OOS/OOT investigations, manufacturing and testing deviations; and audit support. Aaron received his B.S. in Cell and Molecular Biology from Oklahoma State University and his Ph.D. in Biochemistry from the University of Oklahoma Health Sciences Center.

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