1. Brenton T. Smith, PhD, PMP
4 Gaucho Rd Brenton.T.Smith@gmail.com Cell: (484) 356-6411
Ladera Ranch, CA 92694 http://www.linkedin.com/in/brentonsmith
SUMMARY
Pharmaceutical project management professional and six sigma green belt certified medicinal chemist
with 12+ years of project management and project lead experience, advancing projects through
development including review of pipeline portfolios and due diligence for third party acquisitions.
Experienced in GLP, GMP, and GCP regulations. Effective manager and mentor who actively
contributes to the resolution of scientific and administrative issues. Possesses excellent communication,
organizational, and time management skills.
CERTIFICATIONS
Project Management Professional Certification – PMP# 1413368
EDUCATION
PhD, Medicinal Chemistry, University of Kansas, 2002
BS, Chemistry, University of Vermont, 1997
PROFESSIONAL EXPERIENCE
ALLERGAN, Irvine, CA
Consulting- Project Manager Feb 2016 - Present
KINDRED BIOSCIENCES Inc., Burlingame, CA
Associate Director Product Development May 2015 – Jan 2016
• Developed and tracked both product development and launch plans, including budgets/timelines, for
multiple therapeutic areas
• Oversaw 5-year forecasts/margins/revenue/ROI/COGS for all projects
• Coordinated various marketing surveys for early stage PoC/feasibility, pricing studies, and customer
wants/needs
• Managed CMC timelines and submissions
• Responsible for CRO and CMO oversight
• Negotiated CRO study costs and timelines
• Managed/Negotiated CMO preapproval studies/Validation batches/COGS
• Negotiated with vendors for API/primary packaging/secondary packaging
VIRBAC USA, Fort Worth, TX
Sr. Product Development Manager December 2013 – May 2015
Development Manager March 2011 – December2013
• Led multi-disciplinary teams (16-24) for FDA/VDD/EPA submissions and registrations in various
therapeutic areas
• Developed and managed project timelines, budgets, studies, and assigned action items for projects
• Scheduled, managed, and documented project team meetings
• Provided new product assessment including market assessment, risk analysis, due diligence, and
regulatory strategy
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• Developed 3-year forecast including cost of goods/margin/return on investment
• Worked with marketing on “voice of the customer” needs to obtain optimal claims on products
• Designed product launch strategy (Marketing) and conducted training of sales team
• Prepared submissions to regulatory agencies
• Negotiated with the FDA/VDD/EPA on data requirements/needs (both face-to-face and via phone)
• Developed master labels (claims, disclaimers, use, etc.) for submission to regulatory agencies
• Prepared and managed CMC sections for submission
• Negotiated CRO study costs and timelines and provided CRO and CMO oversight
• Developed and monitored GLP preclinical studies and GCP clinical studies
• Developed and managed child resistant packaging studies
Continuing Education at Virbac Corp.
• Project management training-PMP certified
• FDA - GLP and GCP regulations
• EPA - Regulatory affairs and GLP regulations
• Advanced Microsoft Excel Techniques
• CMC - Preparing CMC sections for NDAs/INDs/CTDs
• Leadership, Power, Influence, Politics and Negotiations in Project Management
• Successfully Managing People
• Leading With Emotional Intelligence
DUPONT CROP PROTECTION, Newark, DE
Research Associate May 2010 - October 2010
Senior Research Chemist November 2007 - May 2010
Research Chemist June 2004 - November 2007
• Lead champion of three lead areas overseeing multi-disciplinary teams including chemistry,
toxicology, process development/manufacturing and biological testing for promotion to next phase
of development (Project Management)
• Six Sigma Green Belt Certified
• Simultaneously managed 10-20 different projects, both internal to DuPont and externally at CRO’s
• Responsible for early process development for large-scale synthesis/manufacturing
• Oversight of competitive pipeline portfolios and due diligence on acquisition of 3rd party products
• Led biannual competitive patent review team. Wrote, peer-reviewed, and searched patents utilizing
various patent databases
• Gave regular presentations on Hit/Lead areas to upper management for advancement decisions
• Managed 1-2 direct reports (bachelor-level chemists); Mentored/trained new Ph.D. chemists
• Independently synthesized small molecules for Hit/Lead areas and developed new Hit/Lead areas for
various sites of action
• CRO improvement: Worked with contract labs (India/China) to improve production,
communication, and cycle time for projects
• Performed onsite CRO inspections and evaluations for both discovery and manufacturing
capabilities
• DuPont Knowledge Center (Hyderabad, India): Head chemist for chemistry lab design and
construction as well as purchasing of equipment
• Safety Awareness Committee Chair, responsible for safe laboratory procedures and policies for the
synthetic chemistry and biochemistry labs (2005-2008)
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• Served on the Computational Chemistry Committee
• Recipient of 8 DuPont Certificates of Appreciation, 2 Appreciation Awards, and one Treasure Chest
Plus Award
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Continuing Education at DuPont
• Lead 1 Training- 3 Day leadership class for future leaders of DuPont
• Six Sigma Green Belt training
• Patent Basics for Researchers
• Asia and Middle East Sensitivity training – Training of customs and sensitive issues dealing with
Asia and Middle East (India) CRO’s
UNIVERSITY OF CALIFORNIA, Los Angeles, CA 2002-2004
• Postdoctoral Associate, Michael E. Jung, advisor
PROFESSIONAL AFFILIATIONS
Project Management Institute Member (PMI)
ACS Member/Organic Chemistry Division
ACS Member/Medicinal Chemistry Division
PATENTS, PUBLICATIONS, & PRESENTATIONS
Ten chemistry patents, eleven publications in peer-reviewed journals, and five presentations in regional
and national meetings; available upon request