Manager Chemical Analysis

Andrew W. Buirge

**** ******** **., *********, ** 42301

*********@*****.***

cell270-***-****

Objective

Manager of a QC analytical laboratory

Skills and Accomplishments

. Food, drug, medical device and consumer goods manufacturing

experience.

. Skilled QC analytical/R&D laboratory manager w/10 direct reports.

. ISO 9001/17025 compliance experience in manufacturing environment.

. Laboratory quality system development and cGMP writing and auditing.

. Continuous Improvement and metrics monitoring experience.

. Developed intellectual property for implantable drug delivery.

. Safety officer trained in OSHA regulations.

. Proficient in LIMS and SQL query for laboratory management.

Professional Experience

Manager, Chemical Analysis Swedish Match North America

Owensboro, KY-2009 to present.

. Crafted ISO 17025 quality system for Chemical Analysis, North America.

. Ensured compliance to FDA regulations.

. Design and implement C.I. projects.

. Directed method development and validation.

. Performed analyst reviews on a quarterly basis.

. Provide daily direction for analytical laboratory staff.

. Conducted OOS result root cause analysis and implemented corrective

actions

. Approved equipment/software purchases.

. Increased employee engagement from 70% - 100%

. Improved efficiency of Chemical Analysis by 75%

. Responsible for entire North American laboratory budget.

. Assist in trouble shooting GMP production process.

. Reported group progress directly to upper management in Stockholm,

Sweden.

CSO, Aim & Act, Inc.

Bozeman, MT - 2006 to 2009.

. Crafted quality system for contract generic solid dosage pharmaceutical

testing lab.

. Developed HPLC & GC analytical methods for pharmaceuticals.

. Validated analytical equipment and methods for generic solid dosage

testing.

. Performed QA audits for cGXP process.

. Provided regulatory compliance guidance to manufacturers.

. Recommended new equipment purchases to meet ICH/FDA test guidelines.

. Calibration, maintenance and qualification of analytical equipment per

quality system guidelines.

. Managed identity, strength, quality, purity and packaged stability

study programs.

Plant Manager/Production Coordinator, International Malting Company

Milwaukee, WI - 2004 to 2006

. Crafted cGMP documentation for FDA regulated lean manufacturing

process.

. Managed supervisory personnel in GMP production environment.

. Performed OSHA safety inspections compliant to 29 (CFR) 1910.

. Developed process validation methods to support production.

. Trained production supervisors in GMP production guidelines.

. Validated cleaning protocols.

Cancer Information Specialist

Minneapolis, MN / Great Falls, Mt - 2000 to 2004

. Recorded and tracked patent treatment plans and outcomes.

. Interfaced between physicians and support staff.

. Supplied critical pharmaceutical data to regulatory agencies for

standard of care.

Senior Scientist, Pharmatarget Inc.

Maple Grove, MN - 1996 to 2000

. Established pharmaceutical testing laboratory for FDA submission data.

. Developed and validated analytical pharmaceutical methods.

. Calibrated and validated equipment used to generate FDA submission

data.

. Researched pharmaceutical impurities evolving upon in-vitro studies

for implant device.

Scientist, Scimed division of Boston Scientific, Inc.

Maple Grove, MN - 1991 to 1996

. Characterized pharmaceutical dissolution profiles with modified USP

apparatus 1 and 2.

. Established drug delivery implant testing laboratory.

. HPLC method development and equipment validation.

. Developed implantable drug delivery device technology and intellectual

property.

Synthetic Chemist, INC Star Corporation

Stillwater, MN - 1990 to 1991

. Synthesis and characterization of radioactive tracers for RIA.

. HPLC purification of radio labeled hormones.

. Performed GMP process transfer from Baxter Clinical Assay line.

Assist. Scientist, Ecochem Research Inc.

Chaska, MN - 1988 to 1990

. Synthesis, purification and characterization of new pharmaceutical

compounds.

. Developed analytical methods for new molecules.

. Managed synthetic lab support staff.

Laboratory Manager, Advanced Circuits, Military Division

Minnetonka, MN - 1987 to 1988

. Managed plating chemistry analytical lab and technicians.

. Wrote SOP documents for existing analytical chemistry procedures.

. Audited GMP production.

Undergraduate Professional Experience

Synthetic Chemistry Technical Aide, 3M, Central Research, Graphic Research

Laboratories

Maplewood, MN - 1983 to 1987

. Synthesis and characterization of polymers and dye molecules.

. Developed new polymerization techniques and functionalized acrylate

monomers.

Teaching Assistant, Macalester College, Chemistry Department, St. Paul, MN

- 1982-1987

Education

University: Macalester College, St. Paul Minnesota - 1981 to 1987

Degrees: Bachelor of Sciences in Chemistry, ACS certified honors

graduate, Macalester College, 1987

Awards:

Outstanding Experimental Chemist

Letter of Academic Achievement

Outstanding Sophomore Chemist

Beltman Fellow

Bush Fellow

Professional Training

. Good Laboratory Practice, 21CFR 58

. Good Manufacturing Practice

. World Class Management Practice

. World Class Manufacturing Practice

. Continuous Improvement

. OSHA 29 CFR 1910, including part 1903, 1904, 1928

. Conflict Resolution

. Regulatory Compliance for Drugs, Device and Food

. Dale Carnegie sales training

. ISO 17025 Quality system auditing.

. Validation of analytical equipment & methods

. Technical Management

Professional Affiliations

. American Chemical Society

. CORESTA

. Society for Controlled Release

. Adhesion Society

. Society for Biomaterials

. Who's Who Worldwide Registry

. AOAC

Publications

Buirge, A. W., et al, "Tumor Reactive cis-Aconitylated MaBs Coupled to

Daunorubicin through a Peptide Spacer are Unable to Kill Tumor Cells", Anti-

Cancer Research, vol. 10, no. 3, 1990.

Karu, A.E., et al, "MaB Based Immunoassay of Cyclodienes", Sixth Annual

Waste Testing and QA Synopsis, Grand Hyatt, Washington D.C., July 16-20,

1990.

Buirge, A.W., et al, "A Convenient Preparation of 3-Aryl-3', 4-

Dihydroisocoumarins: Synthesis of the Naturally Occurring Sweetener,

Phyllodulcin", JOC, v.10, no. 8, 1988.

Buirge, A.W., "Synthesis of Cyanobacterin Analogs and Silver Assisted

Organic Synthesis", Macalester College Press, 1987.

Patents

. Polymerizable Balloon Implant Device, U.S. Patent 5,443,495,

08/22/1995

. Collagen Sleeve for Vascular Stent, U.S. Patent 5,693,085, 12/02/1997

. Intravascular Stent-Pump, U.S. Patent 5,735,897, 04/17/1998

. Implantable Resorbable Drug Dispensing Device, U.S. Patent 5,735,897,

04/07/1998

. Stent Delivery Apparatus and Method, U.S. Patent 5,989,280, 11/23/1999

. Stent With Collagen, U. S. Patent 6,391,052, 05/21/2002

. Stent Delivery Apparatus and Method, U.S. Patent 6,530,947, 03/11/2003

. Stent Delivery Apparatus and Method, U.S. Patent 7,001,423, 02/21/2006

Presentations

28th ACS Research Symposium, Total Synthesis of the Naturally Occurring

Sweetener Phylodulcin, 1985

29th ACS Research Symposium, Synthesis of Cyanobacterin Analogs, St. Paul,

MN, 1986

30th ACS Research Symposium, Synthesis of Cyanobacterin Analogs, St. Paul,

MN, 1987

Macalester College Guest Lecturer, Molecular Architecture in the Twin

Cities, St. Paul, MN, 1988

American Heart Association Poster Session, Procainamide Degradation Study,

Dallas, TX, 1998

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