Experience

Aronora, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, CMC

  • Aug 2022 - Present

  • Oversee CMC-related activities to ensure safety, quality, efficacy, and consistency for multiple drug candidates through partnerships with domestic and international CROs/CMOs • Manage collaborations with domestic and international CMOs and CROs for critical CMC activities including bacterial and mammalian cell line development, process optimization, lot release testing, and stability programs • Preparation and quality review of technical reports, manuscripts, clinical protocols, IND… Show more • Oversee CMC-related activities to ensure safety, quality, efficacy, and consistency for multiple drug candidates through partnerships with domestic and international CROs/CMOs • Manage collaborations with domestic and international CMOs and CROs for critical CMC activities including bacterial and mammalian cell line development, process optimization, lot release testing, and stability programs • Preparation and quality review of technical reports, manuscripts, clinical protocols, IND modules and other FDA communications for biologics drug candidates and assessment of CMO/CRO contract budgets and scopes

• Senior Scientist

  • Jun 2018 - Aug 2022

  • Manage collaborations with CMOs and CROs for critical CMC activities including bacterial and mammalian cell line development, process optimization, lot release testing, and stability programs • Develop analytical assays to be used for lot release/stability testing and clinical sample testing (e.g. immunogenicity tests), draft protocols, oversee transfer, validation, testing, and track deliverables by CROs • Perform analytical assays on clinical samples, statistical analysis of clinical… Show more • Manage collaborations with CMOs and CROs for critical CMC activities including bacterial and mammalian cell line development, process optimization, lot release testing, and stability programs • Develop analytical assays to be used for lot release/stability testing and clinical sample testing (e.g. immunogenicity tests), draft protocols, oversee transfer, validation, testing, and track deliverables by CROs • Perform analytical assays on clinical samples, statistical analysis of clinical data, and review of phase 1 and phase 2 trial data collected by clinical CROs • Preparation and quality review of technical reports, grant applications, manuscripts, clinical protocols, IND modules and other FDA communications for biologics drug candidate

• Research Scientist

  • Jan 2015 - Jun 2018

  • Design, coordinate, and conduct experiments for further defining mechanism of action and molecular properties of prospective drug candidates, primarily for a recombinant enzyme product • Develop analytical assays to be used for lot release/stability testing and clinical sample testing (e.g. immunogenicity tests), draft protocols, oversee transfer, validation, testing, and track deliverables by CROs • Facilitate GMP manufacturing of complex biologic drug substance at CMO through batch… Show more • Design, coordinate, and conduct experiments for further defining mechanism of action and molecular properties of prospective drug candidates, primarily for a recombinant enzyme product • Develop analytical assays to be used for lot release/stability testing and clinical sample testing (e.g. immunogenicity tests), draft protocols, oversee transfer, validation, testing, and track deliverables by CROs • Facilitate GMP manufacturing of complex biologic drug substance at CMO through batch record drafting, technical and scientific support, on-site process monitoring, and quality review of executed batch records • Preparation and quality review of technical reports, grant applications, manuscripts, clinical protocols, IND modules and other FDA communications for biologics drug candidate



OHSU | Oregon Health & Science University

• Research Associate

  • Jul 2014 - Present

  The purpose of my academic research is to study how hypoxia and HIFs affect the chondrocyte phenotype in both articular chondrocytes and the stem cells we induce towards this lineage. I am also interested in the role of HIFs in arthritic diseases and the intersection between hypoxic and inflammatory factor-mediated signaling.

• Post-doctoral Fellow

  • Apr 2010 - Jul 2014

  Worked in Brian Johnstone's lab in the Department of Orthopaedics & Rehabilitation studying mesenchymal stem cell chondrogenesis and cartilage biology & pathology, specifically interested in the effects of hypoxia on these processes



University of Portland

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Assistant Professor / Lecturer

  • Sep 2012 - May 2014

  Portland, Oregon Area * Adjunct Assistant Professor of Math Department, Instructor for Math 161 (Statistics) - Fall 2013 * Lecturer for Mechanical Engineering 461/561 (Biomaterials) - Fall 2012, Spring 2014

• Graduate Research Assistant

  • 2004 - 2010


The University of Queensland

• Higher Education
• 700 & Above Employee

• Whitaker International Fellow

  • Aug 2008 - Aug 2009

  Brisbane, Australia Worked in Justin Cooper-White's lab developing techniques for controlling stem cell aggregate size with microwell surfaces and studying the effects of hypoxia on mesenchymal stem cell chondrogenesis; also used soft lithography to fabricate microbioreactors from silicon-based polymers and evaluated their use for high density stem cell applications (hematopoietic & mesenchymal)



ALZA Corporation

• United States

• Chemical Engineering Intern

  • May 2004 - Aug 2004

  Mountain View, CA Worked in the OROS Formulations Group, characterizing and optimizing a drug delivery platform by evaluating its release behavior and investigating alternative polymers for formulations

• Chemical Engineering Co-op Student

  • Jan 2003 - Jul 2003

  Mountain View, CA Worked in the OROS Formulations Group, characterizing and optimizing a drug delivery platform by evaluating its release behavior and investigating alternative polymers for formulations



Boston University

• United States
• Higher Education
• 700 & Above Employee

• National Science Foundation Undergraduate Research Assistant

  • Jun 2002 - Aug 2002

  Boston, MA Worked in the lab of Joe Tien, conducting research for design of dynamic substrate for tissue engineering project utilizing photolithography and soft lithography with silicon-based polymer