Dennis L. Doerfler

Dennis L. Doerfler

Home Address:

**** ******** **** **.

St. Charles MO 63304-5065

Phone: 636-***-****

Cell: 314-***-****

http://www.linkedin.com/in/dennisdoerfler

abgw5r@r.postjobfree.com

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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