DENISE L. COOK

Philadelphia, PA abp68z@r.postjobfree.com Mobile: 484-***-****

Master of Science in Pharmacology & Toxicology 2008

EDUCATION

University of the Sciences in Philadelphia (USP), Philadelphia, PA

Graduate Student Assistantship, Department of Pharmaceutical Sciences

Thesis Title: Effect of gender on phase I and phase II metabolism of the nephrotoxicant

N-(3,5-dichlorophenyl)succinimide

Induction into Rho Chi Pharmacy Academic Honor Society

Master of Business Administration Expected 2014

Temple University, Fox School of Business, Philadelphia, PA

Concentration in Pharmaceutical Management

Bachelor of Science in Chemistry 2004

Ursinus College, Collegeville, PA

Ursinus College Achievement Grant

HPLC, UPLC, LCMS, GCMS, GC-FID, TLC, UV/Vis, IR, Dissolution, Wet Chemistry &

SKILLS

Enzyme Assays. Waters Empower & Millenium, Agilent ChemStation, Microsoft Word,

Excel, PowerPoint, SharePoint & Access, SigmaStat & SigmaPlot.

Senior Analytical Chemist, R&D, URL Pharma, Philadelphia, PA 2011 Present

INDUSTRY

Lead analytical activities related to drug product development from conception through

EXPERIENCE

approval and method transfer for solid dosage forms.

Communicate analytical data critical to project progression at project team meetings.

Develop methods and write validation protocols to test raw material, in-process material and

finished products according to GMP, USP and ICH standards.

Prepare method development reports, method validation reports, SOPs, technical

presentations and documents related to FDA Information Requests and Deficiency Letters.

Author CMC sections of eCTD filings to support IND, NDA and ANDA applications.

Support technical writers in preparing analytical methods of testing.

Design experiments for and distribute work among junior team members during development,

validation, stability and investigational testing.

Perform user testing, and participate in design and validation of electronic quality systems.

Analytical Chemist, R&D, URL Pharma, Philadelphia, PA 2008 2011

Led analytical projects from conception through approval and method transfer.

Developed and validated methods to test raw material, in-process material and finished

products according to GMP, USP and ICH standards.

Prepared method development reports, method validation protocols, method validation

reports, technical presentations and CMC sections to support IND, NDA and ANDA filings.

Supported technical writers in preparing analytical methods of testing and reviewing technical

documents.

Performed routine analyses to support formulation, release and stability studies.

Analytical Chemist, Analytic Bio-chemistries Inc., Feasterville, PA 2003 2008

Performed drug screens and quantitations on human specimen using HPLC, GC-FID,

GCMSMS, TLC, UV/Vis, colorimetry and immunoassays, such as ELISA, RIA and FPIA.

Developed bioanalytical assay methods for forensic and clinical testing.

Optimized existing assays to reduce analysis time and achieve greater throughput.

Graduate Student Researcher, Dept. of Pharmaceutical Sciences, USP, Philadelphia, PA 2004 2008

RESEARCH Designed and conducted in vitro enzyme assays to evaluate metabolite formation.

EXPERIENCE Optimized and streamlined existing HPLC methods for more efficient metabolite quantitation.

Determined statistical significance of results using SigmaStat software platform.

Presented formal seminars at research conferences and departmental events.

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