
Timeline
About me
Branch Chief (Supervisory Chemist) at FDA
Education

Colorado school of mines
2005 - 2009Bachelor of science (bs) chemical and biochemical engineering 3.7Activities and Societies: Tau Beta Pi, Sigma Nu, Order of Omega Magna cum laude

University of kansas
2009 - 2013Doctor of philosophy (phd) bioengineering 3.96Activities and Societies: Graduate Engineering Association Final Defense with Honors on December 9th, 2013
Experience

Sandoz
Jun 2007 - Jul 2008Technical services internAnalyzed control charts for various solid dosage manufacturing processes to reestablish control limits with FDA.Evaluated feasibility of automated screening and filling process for colloidal silicon dioxide.Performed dissolution studies for various capsule types.

Colorado school of mines
Sept 2008 - May 2009Undergraduate research assistantUse of combustion synthesis to develop bone-replacement materials for use in hip implants

University of kansas
Aug 2009 - Dec 2013Use of computer-aided molecular design to identify stabilizers for lyophilized protein formulations. Solution of the optimization problem focused on stochastic methods.Development and cross-validation of QSPR/QSAR models for reliable prediction of relevant properties for molecular design. Statistical methods were used to estimate the uncertainty in property prediction for computational molecular design candidates. Use of computer-aided methodologies for the combined design of ionic liquid entrainers and extractive distillation processes for the separation of azeotropes. Show less
Graduate Teaching Assistant
May 2012 - Dec 2013PhD Candidate and Graduate Research Assistant
Aug 2009 - Dec 2013

Technical university of denmark
May 2010 - Jul 2010Visiting scholarDeveloped thermodynamic (activity coefficient) models for ionic liquid systems. The models were implemented in ICAS software. A CAMD (computer-aided molecular design) framework was developed to select ionic liquids for use as entrainers in extractive distillation processes.

Purdue university
Aug 2012 - Dec 2012Visiting scholarMeasured aggregation following lyophilization for a variety of protein and excipient combinations. Characterized aggregation through use of UV-Vis, SEC and SDS-PAGE. Characterized lyophilized solids using pxrd. Utilized design of experiments.

Fda
Apr 2014 - nowI oversee the quality assessment of liquid-based generic drug products assigned to the branch, including bio INDs, Pre-ANDAs, ANDAs, and DMFs. In addition, I assist with responding to controlled correspondences. My branch is responsible for assessing a variety of complex generic products, including drug-device combination products, topical semisolids, peptides, and extended-release injectables.I am a member of the UAT for OPQ's Knowledge-Aided Assessment and Structured Application (KASA) project, working to modernize our assessments with state of the art knowledge management and analytics for better regulatory decision-making. Show less
Branch Chief
Sept 2020 - nowSenior Chemist
Aug 2018 - Sept 2020Quality Assessment Lead (Acting)
Jan 2017 - Sept 2020Review Chemist
Apr 2014 - Jul 2018
Licenses & Certifications

Implementing winning strategies
Columbia business schoolMar 2021
Driving digital transformation
Imd business schoolJul 2021- View certificate

Be the manager people won't leave
LinkedinJul 2022 
Leveraging neuroscience for team performance & impact
Duke corporate educationMar 2022
Honors & Awards
- Awarded to Brock RoughtonDissertation Defense with Honors School of Engineering, University of Kansas Dec 2013
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