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Aaron Mclain Email & Phone Number
Consultant
at
Biologics Consulting
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Aaron Mclain is listed as Consultant at Biologics Consulting, based in Tulsa, Oklahoma, United States. AeroLeads shows a matched LinkedIn profile for Aaron Mclain.
Aaron Mclain previously worked as CMC Consultant at Biologics Analytical Development Consulting, Llc and Associate Director at Aurinia Pharmaceuticals Inc.. Aaron Mclain holds Doctor Of Philosophy (Ph.D.), Biochemistry from University Of Oklahoma Health Sciences Center.
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Biologics Consulting
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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:
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12 roles
Aaron Mclain work experience
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Cmc Consultant
Current
Biologics Analytical Development Consulting, Llc
Using my experience in strategic CMC planning and analytical development/quality control technical expertise I assist companies with a wide variety of biologics CMC activities and/or establishment of biologics focused services.
May 2024 - Present
Associate Director
At Aurinia I was the CMC Analytical Lead for Aurinia’s emerging biologics development programs and key member of the CMC team, responsible for setting the long-term CMC goals and strategy for the program. Key achievements and activities leading to a successful IND submission for the companies first biologic include: Completing method development and.
Jan 2023 - Feb 2024
Principal Scientist
At Aimmune I served as the analytical lead for Palforzia Life Cycle Management (LCM) activities, addressing post-approval commitments for the program and analytical lead for the CDX-6114 Phase 1 development program. In this role I represented the analytical development function in the broader CMC organization and interfaced with quality assurance, quality.
Jul 2022 - Jan 2023
Senior Scientist Ii
At Nektar, I was the team lead for CMO analytical operations for numerous biologics programs, and all GMP analytical activities for Nektar’s biologics programs, including release/stability testing, method transfer and validation. I was also a key member of the internal CMC teams and the external integrated development team supporting the Nektar/BMS BemPEG.
Jan 2022 - Jun 2022
Senior Scientist
Jan 2021 - Jan 2022
Scientist Ii
Jan 2019 - Jan 2021
Scientist
Dec 2016 - Jan 2019
Research Scientist
As a member of the Analytical Development Team I managed a team providing analytical support for manufacturing biopharmaceuticals at Cytovance Biologics. During my time at Cytovance I developed and intimate knowledge of method development and validation, a solid understanding of process and formulation development, and GMP processes.
Mar 2015 - Nov 2016
Postdoctoral Associate
Postdoctoral research with Ira Blader Ph.D. Molecular parsitology with a focus on host-parasite interaction using Toxoplasma gondii as a model organism. Molecular biology including qPCR, plasmid construction and expression in mammalian and bacterial systems; Immuno-fluorescence microscopy; Cell culture; Analyzed/interpreted data; Presented data at regional.
Sep 2013 - Feb 2015
Temporary Postdoctoral Associate
Postdoctoral research with Luke Szweda Ph.D. Continued graduate research and prepared manuscripts for future publication
May 2013 - Sep 2013
Graduate Research Assistant
University Of Oklahoma Health Sciences Center-Omrf
Graduate research with Luke Szweda Ph.D.Biochemistry including HPLC analysis of metabolites and small molecules, Enzyme assay kinetics, Protein purification, Western Blotting and Mass spectrometry; Trouble shooting experiments; Analysis and interpretation of data; Wrote and published one first author manuscript and one review article for peer-reviewed.
Aug 2007 - May 2013
2 education records
Aaron Mclain education
Doctor Of Philosophy (Ph.D.), Biochemistry
Bachelor Of Science (Bs), Biochemistry, Cell And Molecular Biology
FAQ
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What company does Aaron Mclain work for?
Aaron Mclain works for Biologics Consulting.
What is Aaron Mclain's role at Biologics Consulting?
Aaron Mclain is listed as Consultant at Biologics Consulting.
Where is Aaron Mclain based?
Aaron Mclain is based in Tulsa, Oklahoma, United States while working with Biologics Consulting.
What companies has Aaron Mclain worked for?
Aaron Mclain has worked for Biologics Consulting, Biologics Analytical Development Consulting, Llc, Aurinia Pharmaceuticals Inc., Aimmune Therapeutics, and Nektar Therapeutics.
How can I contact Aaron Mclain?
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What schools did Aaron Mclain attend?
Aaron Mclain holds Doctor Of Philosophy (Ph.D.), Biochemistry from University Of Oklahoma Health Sciences Center.
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