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Quality Assurance Development

Location:
Algonquin, IL, 60102
Salary:
70,000
Posted:
August 13, 2012

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Resume:

BRIAN GRABOWSKI

*** ****** *****

Algonquin, Illinois 60102

C 224-***-****

dxx3lr@r.postjobfree.com

SUMMARY

Detail-oriented Research Scientist with more than 15 years of experience in the pharmaceutical industry seeking a business development or technical support position. Certified coach mentoring student athletes and adults in sports and fitness.

EXPERIENCE

Technical area expert in support of drug development for submission to FDA, providing metabolism and kinetics of xenobiotics in mammalian systems using in vitro and in vivo techniques. Collaborate with colleagues in various disciplines (Statistics, Clinical Operations, Pharmaceutical Development, Project Management, Quality Assurance and Medical Writing) to successfully develop drugs in various therapeutic areas. Author of several journal publications and presentations regarding pharmaceutical research outcomes.

Instructor providing tennis and fitness coaching 2012 to present

• Staff member at Dundee Crown High School, IL

• Instructor at Crystal Lake Park District, IL

Consultant on Development Strategy 2011 to present

• Provide contract research support services for drug development.

• Investigational New Drug strategy and support in drug metabolism and pharmacokinetics.

• Author manuscript, which provided clinical ADME outcome for journal publication.

Targacept, Inc. Winston-Salem, NC 2011- 2011

Sr. Staff Scientist in Translational Medicine Department

• Evaluated the pharmacokinetics of candidate compounds for neuroscience projects.

• Provided focus on process for business and regulatory issues.

• Vendor evaluation, technical audit and oversight.

Takeda Global Research and Development (US), Deerfield, IL 2008-2010

Clinical Pharmacologist in Clinical Pharmacology Department

• Authored 2 manuscripts, which provided clinical ADME and DDI outcomes for journal publications.

• Prepared and presented clinical study synopses (DDI and ADME) to Senior Review Committee for approval and protocol development.

• Conducted pharmacokinetic analysis of compounds for therapeutic area drug development (GI, Anti-Gout, and Anti-Diabetic) for regulatory filing and post-marketing evaluation.

• Produced pharmacokinetic sections in Clinical Statistical Reports.

• Provided internal presentations for interdisciplinary review and discussion.

TAP (Takeda/Abbott) Pharmaceutical Products Inc., Lake Forest, IL 1999-2008

Sr. Research Scientist in Drug Metabolism and Pharmacokinetics Department

• Presidents Award in 2005 for successful Uloric NDA.

• Worked with clinical teams to ensure a coordinated effort with regard to timelines from protocol submission through final reports.

• Reported data generated in the form of standardized departmental reports and conducted presentations to project teams to improve product development.

• Experienced in technologies for the detection of drugs including high performance liquid chromatography and mass spectrometry.

• Implemented and managed bioanalytical analysis and subsequent pharmacokinetic analysis of pharmacologic entities for drug development.

• Directed and reviewed bioanalytical sample analysis from contract laboratories.

• Provided pharmacokinetic and metabolism (ADME) data analyses in support of preclinical and clinical drug development.

Abbott Laboratories PPD, Abbott Park, Illinois 1990 - 1999

Associate Pharmacologist in Drug Metabolism Department

• Contributed to successful NDA filings (Ritonavir, Kaletra and Zemplar).

• Implemented and conducted drug metabolism studies using radiolabeled and non-radiolabeled drug compounds.

• Co-authored and authored Drug Metabolism reports/publications.

• Utilized LC/MS/MS (LCQ and Sciex) technology to analyze in vivo and in vitro metabolism samples for drug structural elucidation to characterize metabolic pathways.

• Developed HPLC methods for analyzing drug compounds and related analogs.

• Improved techniques utilizing hepatocytes, microsomes and liver slice for determining metabolic schemes, species comparisons and rates of metabolism.

EDUCATION

Bachelor of Arts: Major Biology, Minor Education, North Central College, Naperville, IL

Recent Publications

Brian Grabowski and Ronald D. Lee. Absorption, Distribution, Metabolism and Excretion of [14C]Dexlansoprazole in Healthy Male Subjects. Clinical Drug Investigation May 1, 2012.

32(5):319-332,

Brian A. Grabowski, Reza Khosravan, Jingtao Wu, Laurent Vernillet and Christopher Lademacher. Effect of Hydrochlorothiazide on Pharmacokinetics and Pharmacodynamics of Febuxostat, a Non-Purine Selective Inhibitor of Xanthine Oxidase. Brit J Clinical Pharmacol 2010; 65(3):355-365.

Brian A. Grabowski, Reza Khosravan, Laurent Vernillet, Darcy J. Mulford. Metabolism and Excretion of [14C] Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase, in Healthy Male Subjects. J Clinical Pharmacol March 2010 .

Khosravan R, Grabowski BA, Wu JT, Joseph-Ridge N, Vernillet L. Pharmacokinetics, pharmacodynamics and safety of febuxostat, a non-purine selective inhibitor of xanthine oxidase, in a dose escalation study in healthy subjects. Clin Pharmacokinet 2006; 45:821-841.

Reza Khosravan, Michael Mayer, Brian Grabowski, Laurent Vernillet, Jing-Tao Wu, and Nancy Joseph-Ridge. TAP Pharmaceutical Products Inc. Lake Forest, IL. – The Effect of Mild and Moderate Hepatic Impairment on Pharmacokinetics, Pharmacodynamics, and Safety of Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase. J Clinical Pharmacol 2006; 46:88-102.

Carr R.A., Andre A.K., Chen P., Grabowski B.A., Chang M.S., Locke C.S., Williams L.A., Chojkier M. The Effect of Hepatic Insufficiency on the Safety and Pharmacokinetics of Paricalcitol (Zemplar™). Nephron Clinical Practice 2006.

Representative Poster Presentations

Brian Grabowski, Ronald Lee, Richard Czerniak

Takeda Global Research and Development Department of Drug Clinical Pharmacology, 675 N. Field Drive, Lake Forest, Illinois. Metabolism And Excretion Of [14C]TAK-390 In Healthy Male Subjects. ISSX Conference 2008

Ronald Lee, Brian Grabowski, Darcy Mulford, Neal Castagnoli, Antje Rottmann and Kristof Chwalisz. TAP Pharmaceutical Products Inc., Lake Forest, Illinois. Metabolism and Excretion of Asoprisnil, a Novel Selective Progesterone Receptor Modulator, in Healthy Female Subjects. ISSX Conference 2006

Brian A. Grabowski, Laurent Vernillet, Reza Khosravan, Jing-Tao Wu, Nancy Joseph-Ridge, Darcy J. Mulford. TAP Pharmaceutical Products Inc., Lake Forest, Illinois. Metabolism and Excretion of [14C] Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase, in Healthy Male Subjects. ISSX/JSSX Conference 2005

Reza Khosravan, Michael Mayer, Brian Grabowski, Laurent Vernillet, Jing-Tao Wu, and Nancy Joseph-Ridge. TAP Pharmaceutical Products Inc. Lake Forest, IL. Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase - Effect of Mild and Moderate Hepatic Imparment on Pharmacokinetics, Pharmacodynamics, and Safety. ACCP 2004

Brian Grabowski, Reza Khosravan, Laurent Vernillet, Jing-Tao Wu, Nancy Joseph-Ridge, and Darcy Mulford. TAP Pharmaceutical Products Inc. Lake Forest, IL. Pharmacokinetics, Pharmacodynamics, and Safety of Febuxostat (TMX-67), a Non-Purine Selective Inhibitor of Xanthine Oxidase, in Healthy Subjects. ACCP 2004

Robert A. Carr, Ping Chen, Amy Andre, Carol Soltanek, Robert O'Dea, Sheila Gerety, Ali Ahmed, Min Chang, Xin Ye, George Nequist, Brian Grabowski. Abbott Laboratories, Abbott Park, Illinois. Pharmacokinetics (PK) and Safety of Paricalcitol (Zemplar, ZMP) in Subjects with Mild to Moderate Stabilized Chronic Hepatic Insufficiency. AAPS 2004



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