Brock Roughton

Brock roughton

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location of Brock RoughtonRockville, Maryland, United States
Phone number of Brock Roughton+91 xxxx xxxxx
  • Timeline

    Jun 2007 - Jul 2008

    Technical Services Intern

    Sandoz
    Sept 2008 - May 2009

    Undergraduate Research Assistant

    Colorado School of Mines
    Aug 2009 - Dec 2013

    Graduate Teaching Assistant

    University of Kansas
    Lawrence, Kansas Area
    May 2010 - Jul 2010

    Visiting Scholar

    Technical University of Denmark
    Aug 2012 - Dec 2012

    Visiting Scholar

    Purdue University
    Current Company
    Apr 2014 - now

    Branch Chief

    FDA
    Silver Spring, Maryland, United States
  • About me

    Branch Chief (Supervisory Chemist) at FDA

  • Education

    • Colorado school of mines

      2005 - 2009
      Bachelor of science (bs) chemical and biochemical engineering 3.7

      Activities and Societies: Tau Beta Pi, Sigma Nu, Order of Omega Magna cum laude

    • University of kansas

      2009 - 2013
      Doctor of philosophy (phd) bioengineering 3.96

      Activities and Societies: Graduate Engineering Association Final Defense with Honors on December 9th, 2013

  • Experience

    • Sandoz

      Jun 2007 - Jul 2008
      Technical services intern

      Analyzed 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 2009
      Undergraduate research assistant

      Use of combustion synthesis to develop bone-replacement materials for use in hip implants

    • University of kansas

      Aug 2009 - Dec 2013

      Use 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 2013
      • PhD Candidate and Graduate Research Assistant

        Aug 2009 - Dec 2013
    • Technical university of denmark

      May 2010 - Jul 2010
      Visiting scholar

      Developed 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 2012
      Visiting scholar

      Measured 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 - now

      I 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 - now
      • Senior Chemist

        Aug 2018 - Sept 2020
      • Quality Assessment Lead (Acting)

        Jan 2017 - Sept 2020
      • Review Chemist

        Apr 2014 - Jul 2018
  • Licenses & Certifications

    • Implementing winning strategies

      Columbia business school
      Mar 2021
    • Driving digital transformation

      Imd business school
      Jul 2021
    • Be the manager people won't leave

      Linkedin
      Jul 2022
      View certificate certificate
    • Leveraging neuroscience for team performance & impact

      Duke corporate education
      Mar 2022
  • Honors & Awards

    • Awarded to Brock Roughton
      Dissertation Defense with Honors School of Engineering, University of Kansas Dec 2013