Training Quality
Resume:
Dennis L. Doerfler
Dennis L. Doerfler
Home Address:
St. Charles MO 63304-5065
Phone: 636-***-****
Cell: 314-***-****
http://www.linkedin.com/in/dennisdoerfler
*********@*********.***
QUALIFICATION SUMMARY
Dependable research professional with extensive experience in a broad range of
pharmaceutical R&D fields including analytical chemistry, biochemistry, organic
chemistry and stereochemistry. Experienced in analytical work involving proteins,
enzymes, peptide hormones, carbohydrates, antibodies, and lipids using complex
instrumentation. Practical, up-to-date experience with cGMP compliance issues,
focusing on laboratory compliance issues and industrial raw materials. Proven ability to
operate within cGMP expectations and adjust to the changing regulatory environment.
Able to supervise technical staff and provide necessary training and direction.
Recognized by peers and co-workers as an adaptable team player who demonstrates
thoroughness and integrity.
WORK HISTORY
1984 – 2011 Pfizer Inc. [formerly Pharmacia / Searle / Monsanto], St. Louis
[currently laid off] (Chesterfield), Missouri
Employed in biologics R&D department. Experience includes six years
of direct supervision. Primary accomplishments have included:
• Created and organized an effective GMP training program for all
of Analytical R&D to maintain compliance. Maintained a system of
recording / archiving completed training records. Organized and
assigned training requirements to align with the duties of personnel.
Personally provided some training, both cGMP and technical.
• Completely created, organized, and maintained an efficient and
effective Raw Material Qualification, analysis program (utilizing
outside analytical laboratories), and release procedure to never
have a delay due to approved raw materials not being available.
• Successfully wrote numerous SOPs for all phases of laboratory
operation / analyses and SOP system administration.
• Reviewed and approved numerous documents, including SOPs,
validation protocols, validation reports, specifications, technical
reports, raw data, stability reports, and results reports to maintain
accuracy, completeness, and compliance.
• Monitored pharmaceutical water systems (including chemical
and microbiological tests) to ensure the quality of the various water
systems [including WFI]. Used ultrasensitive Total Organic Carbon
measurements to validate cleaning and monitor water quality.
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• Participated in external / internal GMP audits. Addressed any
concerns and suggested improvements to bring laboratories into
total compliance. Participated in audits of outside [contract]
analytical laboratories.
• Performed or supervised various analyses of final products,
APIs, intermediates and in-process materials for release.
• Completely established and operated a new reference standard
and control material program for biologics to permit coordinated
and reliable assays.
• Assisted with the establishment of an effective biologics stability
program and prepared some reports / tables for IND/NDA
applications.
• Up to date working knowledge of computers with an emphasis
on computer applications in a laboratory setting and Microsoft
Office [including ACCESS and Project].
• Participated on GLP Committee (Monsanto).
1982 – 1984 Wyeth Laboratories, West Chester, Pennsylvania [plant now closed]
Supervisor of Biochemical Services, Fermentation R&D Department
Responsible for conducting chemical/biochemical analyses to improve
the fermentation process used in the production of penicillin.
• Determined trace components in complex mixtures for yield
improvement and reducing the cost of production.
• Developed and verified new analytical procedures to expand
knowledge about the production of penicillin.
• Developed an automated assay system for enzymatic activity to
allow easy measurement of deacylating activity.
• Built new or modified electronic equipment to optimize and
simplify the control of fermentation processes in production and in
research.
1980 – 1982 The University of Pittsburgh, Pittsburgh, Pennsylvania
Post Doctoral Appointment
Topic: The biosynthesis and function of secondary metabolites in the
Penicillia and Aspergilli.
• Modified H-P 5985B GC/MS to add an extra channel of data
about radioactivity to allow the tracing of metabolic pathways.
EDUCATION
The University of Pittsburgh, Pittsburgh, Pennsylvania
Ph.D. 1980 Major: Biochemistry (Fungal Secondary Metabolism)
• Studied the isolation, identification and biosynthesis of natural products.
• Involved with many types of chromatography (HPLC, GC, GC/MS, SEC, IEX, TLC).
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Dennis L. Doerfler
• Used mass spectrometry for detection and identification of complex mixtures.
• Modified analytical equipment to incorporate gas flow proportional counters.
• Designed, built and maintained a complete data acquisition and analysis system.
• Designed and built (hardware) computer interfaces for laboratory equipment.
• Taught short course on computer programming and computer interfacing.
• Studied structure and function of parvalbumins from various sources.
• Investigated protein structure by spectroscopy, enzymatic and chemical modification.
The University of Pittsburgh, Pittsburgh, Pennsylvania
Major: Synthetic Organic (Partial synthesis of bicyclohexatriene).
• Used spectroscopic tools [incl. NMR] extensively for compound structure elucidation.
• Studied crystallography and performed detailed X-ray structure determination.
Princeton University, Princeton, New Jersey
Major: Organic Chemistry (Stereochemistry)
• Synthesized and studied the absolute configuration of phosphine oxides.
• Synthesized and characterized metal ion complexes of phosphine oxides.
Earlham College, Richmond, Indiana
BA Major: Chemistry
CONTINUING EDUCATION
• Attended Georgia GMP Conference (6 years)
• ACS course in Analytical Biochemistry
• Course in Instrument Calibration
• Course in all aspects of GLP
• Attended numerous vendor presentations and visits to vendor facilities
• Member in good standing of emergency squad (safety). Have taken all required
courses, including CPR, fire extinguisher, SCBA, first aid, and bloodbourne
pathogens.
• Attended Dale Carnegie Course “Breakthrough to Success” (12 weeks)
• Attended International Reference Standard Symposium (Indianapolis 2007)
• Various web seminars, including GLP, Reference Standards, Raman
Spectroscopy, LC/MS/MS, and General Chromatography.
• Presented talk at 2007 Pittcon entitled, “Starting-up a Developmental Biotech
Reference Standard Program.”
AWARDS
• Partial academic scholarship funded by Lubrizol Company (Earlham College)
• Awarded Andrew Mellon Predoctoral Fellowship (University of Pittsburgh)
• Renewed Andrew Mellon Predoctoral Fellowship (University of Pittsburgh)
• Individual Performance Award (2010 Pfizer)
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SOCIETY MEMBERSHIPS
ACS, ASM, ASMS, and PDA
PUBLICATIONS
Twelve peer reviewed publications
INTERNAL MONSANTO PUBLICATIONS
MSL: Computerization of a Gilford Spectrophotometer to Measure the Color of a
Solution (single value)
RESTRICTION
I am not permitted to work for the Pfizer Company nor in direct competition with the
Pfizer Company.
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