Aaron McLain

About Aaron McLain

I am a CMC consultant with extensive product development experience supporting CMC biologics clinical development and commercial programs with primary technical expertise in analytical development and quality control. Proven capabilities in development and execution of CMC development plans and making strategic data driven decisions to manage development and regulatory risks. Skilled collaborator and capable communicator, able to facilitate cross-functional alignment of program goals, timelines and risks, and concise presentation of data and program metrics to senior leadership. Strong CMC regulatory background, with broad knowledge and experience drafting Module 3 CMC regulatory sections and authoring questions and responses to regulatory agencies. Extensive experience planning and leading GMP and non-GMP activities in both internal labs and across multiple CMO/CRO organizations to support product development and manufacturing.Core Competencies- Strategic CMC planning and risk management supporting pre-IND programs through BLA for drug substance and drug product - Analytical method development, transfer and validation - Analytical characterization and comparability studies - Process and formulation development - Specifications and control strategy for drug substance and drug product - GMP release and stability testing and trending - In-use stability to support use of product at clinical sites- CMC Module 3 regulatory writing and review - CMO selection, management, and auditing - Due diligence and technology selection

Experience

1. Consultant

   Biologics Consulting

   Nov 2024 — Present · Tulsa, OK, US

   CMC consultant with a focus on analytical development, quality control, and formulation development.

Education

• University of Oklahoma Health Campus

  Doctor of Philosophy (Ph.D.), Biochemistry

  2007 — 2013

• Oklahoma State University

  Bachelor of Science (BS), Biochemistry, Cell and Molecular Biology

  2003 — 2007