Bruce Girton
Issaquah, WA, USA bgirton@earthlink.net
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June 4, 2009
Summary
Analytical chemist with 20 years experience
in the biotechnology / pharmaceutical industry, including:
- Quality
control laboratory management in a highly virtualized biotechnology
context.
- Analytical method development, validation, and transfer.
- Preparation and review of documents for US and EU regulatory
submission.
- Development, improvement, and implementation of laboratory
systems.
- Supervision of groups of analytical chemists.
- Expertise in the application of a broad spectrum of laboratory
techniques.
- Development of in vitro enzymatic prodrug characterization
protocols, formulations for
inhaled liquid dosage forms, and intellectual property.
- Master's degree in physical chemistry.
Accomplishments
Pharmaceutical
Development
- Developed familiarity with the chemistry and molecular biology of
platinum-based chemotherapeutic agents.
Guided the development and validation of new or improved methods
for analyzing platinum-based synthetic intermediates, drug substance and
drug product.
- Supported process development, assisting with the resolution of
technical problems and the establishment of process controls.
- Reviewed existing specifications, stability protocols, analytical
methods, method validations, and raw data pertaining to synthetic
intermediates, drug substance and drug product.
- Identified and supported the resolution of analytical and quality
control technical and regulatory compliance risks and issues.
- Developed and sustained effective working relationships with
employees of diverse contract manufacturing and contract research organizations.
- Supported the adjudication of storage or shipping related
temperature excursions.
- Managed a stability program, including detailed data review,
evaluation and reporting.
- Assisted with the preparation of regulatory submissions, including
IND annual
updates and EU Investigational Medicinal Product Dossiers.
- Supported the resolution of several laboratory OOS investigations
and product failure investigations, including:
- Led a project to identify a problematic
process impurity at the 0.01% level, and to develop and validate
analytical methods to control it.
- Led a project to successfully resolve
an apparent OOT/OOS situation by re-optimizing the analytical method to
be more reproducible and by improving the method of interpreting the data
so as to more accurately represent the true characteristics of the drug
product.
- Performed or supervised the development, improvement. validation,
and inter-laboratory transfer of analytical methods for diverse active
pharmaceutical ingredients and dosage forms. Introduced novel analytical
technologies and developed improved laboratory practices.
- Wrote and reviewed numerous technical documents, including NDA CMC
reports, responses to FDA questions, analytical method validation
protocols and reports, laboratory contracts and statements of work, and
analytical methods.
- Supervised groups of analytical chemists.
- Performed analysis and physicochemical characterization of oral,
transdermal, inhaled, and parenteral dosage forms, process intermediates,
and active pharmaceutical ingredients, for release, stability, process
development, and identified process impurities, contaminants and
polymorphs, using a wide variety of modern analytical techniques,
including ion trap and time of flight HPLC-MS.
Pharmaceutical
Discovery
- Developed in vitro enzymatic prodrug characterization
protocols.
- Named as a co-inventor in international patent application
WO 2006/138212.
- Developed formulations for inhaled liquid dosage forms.
- Co-authored an invention disclosure for a novel drug delivery
technology platform.
- Implemented an advanced NCE sample inventory control program.
Pharmaceutical
Quality Laboratory Systems
- Developed and implemented computerized systems leading to improved
efficiency in analytical data reduction, reporting, and document
management.
- Installed, validated, and administered computerized laboratory
data systems.
- Developed and administered reference standard programs.
- Participated in various multifunctional teams, including:
- Supervised two chemists in a laboratory instrument calibration and
maintenance group, supporting sixty analytical development and quality
control chemists.
- Reviewed and authored numerous laboratory standard operating
procedures.
- Participated in quality audits of contract laboratories and
pre-approval inspections.
Employment History
Poniard Pharmaceuticals, Inc. Seattle, WA 2007 – Present
Quality
Control Manager
Corus Pharma, Inc. / Gilead Sciences, Inc. Seattle, WA 2003 – 2007
Senior
Research Scientist
QLT, Inc. Vancouver, BC,
Canada 1999 – 2003
Research
Chemist III, Analytical Development, Scientific Affairs - 3 direct reports.
Scientific
Coordinator, Quality Control, Quality & Regulatory Affairs - 3 direct
reports.
Consultant,
Quality Control & Analytical Development
Cell Therapeutics, Inc. Seattle, WA
1996 – 1999
Systems
Coordinator, Analytical Development, Manufacturing Operations
Research
Chemist, Analytical Development, Manufacturing Operations
Par Pharmaceutical, Inc. Spring Valley, NY 1993 – 1996
Instrument
Group Supervisor, Quality Control - 2 direct reports.
Group
Leader, Analytical Research & Development - up to 6 direct reports.
Novartis, Inc. Suffern, NY 1989 – 1999
Scientist
I, Physical and Analytical Chemistry, Drug Development
Associate
Scientist II, Physical and Analytical Chemistry, Drug Development
Associate
Scientist I, Physical and Analytical Chemistry, Drug Development
Education
M.S. Physical Chemistry
North Dakota State
University, Fargo, ND
Thesis
title: "The Structure and Photochemistry of 9-Hydroxyphenalenethione"
B.S. Chemistry
State University
of New York at Albany,
Albany, NY