SUMMARY

Quality professional with extensive experience in the laboratory, specializing in delivering solutions, results, documentation, and services that meet GMP, GLP regulatory standards. A point of contact for problem-solving and instrument troubleshooting, ability to pay attention to details, handle multiple tasks, and in a timely fashion.

Areas of expertise include: Laboratory, Method transfer/validation, Analytical chemistry, Chromatography, Wet chemistry. Instrumentation/ Equipment: HPLC, FT-IR, ICP, UV/VIS, GC, GC/MS, GPC, Titration (Karl Fisher) Dissolution, KDR.

Key contributor to method optimization resulting in a 50 % reduction in final product used for Content Uniformity, Assay, and Degradation testing.

Successfully completed a very complicated, complex and business critical method transfer from R&D to a Quality Control lab ahead of schedule.

Consistently handled a high volume of testing without analyst error Out of Specification (OOS) or Deviation.

Recognized for outstanding performance in delivering quality testing for a business critical clinical study ahead of schedule.

PROFESSIONAL EXPERIENCE

Takeda, Brooklyn Park, MN 2016- Present

Sr. Quality Control Analyst

Perform validation, and transfer analytical methods in accordance with ICH, USP and GLP guidelines.

Revise, review and author analytical test methods, standard operating procedures, method validation protocols.

Analyze biological and chemical elements as directed by assays using a wide variety of chromatographic and spectroscopic HPLC and UV/VIS system.

Lead Protein A HPLC method validation project, Oligosaccharide method transfer project.

Engage in validation of new analytical test methods. Participate in cross-functional project teams.

Perform technical evaluation of data to analyze, interpret experimental data and write reports.

Maintain data integrity and ensure compliance with company Standard Operating Procedures, specifications and cGMP regulations.

Provides mentoring, training lower level QC analysts.

Maintain, operate and troubleshooting of laboratory instrument / equipment.

Pace Analytical, Oakdale, MN 2014-2016

Senior Chemist

Supported develop of analytical methods for new products using HPLC/UPLC.

Performed routine and non-routine testing in support process validation, stability, and method transfer activities.

Wrote analytical reports, revised test method in support of new product development as well as existing product.

Interpreted experimental data and communicated results to project teams and clients.

Assisted with coordination of workflow, from incoming samples through analysis, to outgoing results to meet the client’s needs such as logged samples, analyzed, and reported results.

Standardized and maintained compliance with documentation practices.

The Experts, Rogers, MN 2013-2014

Chemist (Contractor)

Analyzed and interpreted the data using a wide variety of instrument techniques and provided technical support for lab equipment such as GPC, FTIR, and Karl Fisher Titration.

Authored, and executed method validation protocols. Wrote summary reports.

Reviewed analytical data, method validation, and special studies in accordance with ICH and USP guidelines.

Wrote equipment specification protocols, IQOQ reports, Calibration and Preventive Maintenance Assessment (CPMA) for DSC, and FTIR.

Boston Scientific Corporation, Maple Grove, MN 2004 - 2013

Chemist

Performed routine and non-routine testing on raw material, in-process, particle size distribution analysis, and finished goods product, stability sample using HPLC, GC / MS, FT-IR, GPC, ICP, KDR and Wet Chemistry.

Revised, and updated Standard Operating Procedures, and test methods.

Assisted with implementation of new methods and technologies in the laboratory.

Executed and wrote protocols for method transfer, method validation from R&D laboratory to Quality Control laboratory.

Solved technical problems, out of trend, and out of specification, and wrote experimental plans to identifying and solving problems.

Wrote and executed protocols to validate work sheets used to calculate impurity and degradation products.

Trained new analyst on current methods, cGMP, and GLP

EDUCATION

Bachelor of Science in Chemistry-University of Minnesota, Minneapolis, MN

PROFESSIONAL TRAINING

GC/MS course, fall 2005 (Restek).

Water’s Empower Advanced Training, October 2006.

Troubleshooting HPLC System, summer 2007 (Minnesota Chromatography Forum).

Gas Chromatography course, Feb 2008 (Minnesota Chromatography Forum).

GPC / SEC October 2009 (PSS Polymer Standards Service).

Making HPLC Methods Work, May 2012 (Minnesota Chromatography Forum).

Getting the Most out of Capillary Gas Chromatography, May 2013 (Minnesota Chromatography Forum).

EQUIPMENT

Walter Alliance HPLCs (High-Performance Liquid Chromatography).

Agilent 6890 GC (Gas Chromatography), Mass Spec and FID (Flame Ionization Detector) detection.

Varian ICP-OES (Inductively Coupled Plasma - Optical Emission Spectrometry).

Niollet Omnic FTIR (Fourier Transform Infrared Spectroscopy), and Spectrum two Perkin Elmer FTIR.

Karl Fisher titrations, AA (Atomic-Absorption), UV/VIS (Ultraviolet-Visible Spectrophotometry).

Walter Alliance GPC (Gel Permeation Chromatography), and Perkin Elmer GPC.

Technical Skills

Microsoft Excel, Outlook, Word, PowerPoint 2007 – 2010, JMP, Minitab, Water Empower, Agilent ChemStation, Lab Wizard, LabWare LIMS

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