Analytical Chemist Raw Materials

Carole Bodziuch

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

Riegelsville, PA 18077

Home: 610-***-****

Cell 610-***-****

acq7sf@r.postjobfree.com

Objective

To secure a challenging position where my analytical chemistry background and experience can be utilized.

Summary

Extensive experience as an analytical chemist specializing in pharmaceutical analysis of raw materials, in-process samples, stability samples, and finished products

Types of samples include tablets, capsules, liquids, suspensions, powders, gels and creams.

Participated in writing Method Development and Validation protocols and reports, Stability reports, SOPs, Certificates of Analysis and Methods

Computer proficient with MS Word, Excel, LIMS, Documentum, TrackWise, Millennium, Empower, Open Lab and ChemStation software

Experience in HPLC and GC method development/optimization and validation according to the current USP and ICH guidelines.

Experienced with Shimadzu, Waters, and Agilent HPLCs and Agilent GCs.

Experienced with Distek and VanKel dissolution baths.

Comprehensive experience in water testing, raw material testing and vendor material comparison

Experienced in analyzing informal and formal stability samples according to the current ICH guidelines

Strong analytical expertise in HPLC, AA, Karl Fischer, TGA, DSC, pH, TOC, viscosity, GC, FTIR/ATR, UV-VIS spectroscopy, and dissolution testing

Experience with equipment calibration

cGMP and cGLP literate and compliant

Excellent verbal and written communication skills

Highly motivated; works well in either a team setting or independently

Participated in mentoring/training junior level chemists.

Professional Experience

Lehigh Valley Technologies, Inc, Allentown, PA February 2010-Present

Senior Chemist, R&D/QC

Work with controlled substances (Schedule II and III)

Analytical testing on tablets, capsules, and liquids for assay, related substances, active, and preservative for Stability and R&D samples.

Test raw materials according to the current USP

Participate in writing Laboratory Investigations/Deviations

Participate in revising/updating methods and SOPs

Manage the Raw materials department

In charge of sending out samples for outside testing

Train new analyst

Manage the HPLC/GC column inventory

Review data

Back-up for the supervisor when not available

In charge of the Stability Department for 5 months when the Stability Coordinator was on short term disability

Ortho-McNeil Pharmaceuticals, Inc, Raritan, NJ September 2009-February 2010

US Tech Solutions Inc

Associate Scientist (contract), QC Group/Raw Materials

Testing on purified water, water for injection, raw materials and packaging components

according to the current USP and EP.

Performed instrument qualification.

Writing laboratory investigations, deviations, methods, and SOPs.

Bracco Research USA, Inc, Princeton, NJ March 2009-September 2009

Pharmaceutical Clinical Associates, LLC

Analytical Chemist (contract), Pharmaceutics Group

Informal stability testing on lyophilized products and raw materials

Developed and validated a Karl Fischer method for raw material

Column equivalency study for an HPLC method

Raw material vendor comparison

Customer complaint samples

Updated SOPs and methods

McNeil Consumer Healthcare, Fort Washington, PA October 2007-March 2009

Kelly Management Services

Senior Analyst (contract), New Product Development Group

Analysis and optimization of HPLC methods for active and impurities in liquid, lotion and stick samples.

Pre-validation and informal and formal stability studies on liquid, lotion and stick samples.

Analysis of new products in support of the Formulations Department.

Completed method transfers to J&J, R&D Technical Center, Mumbai, India.

Ortho-McNeil Pharmaceuticals Inc, Titusville, NJ October 2006-October 2007

Kelly Scientific

Analytical Chemist (contract), Method Development Group

Provided support to the Method Development Group including responsibilities for method development, method validation, and writing methods and validation protocols.

Involved in troubleshooting and optimizing analytical methods.

McNeil Consumer Healthcare, Fort Washington, PA, August 2002- September 2006

Tunnell Consulting

Analytical Chemist (contract)

Independently supported stability studies on solid dosage forms and suspensions.

Provided a lead analytical role in the analytical testing of in-process batches for the evaluation and validation of a new manufacturing area. Responsibilities included evaluating trends in the overall data of individual batches indicating possible manufacturing problems.

Participated in studies evaluating the possible interference from filters involved in drug recovery for dissolution testing.

Involved in the validation of both the chromatographic methodology and extraction procedures for cleaning validation swab samples.

TEVA Pharmaceuticals, Sellersville, PA, October 2000- August 2002

Analytical Chemist

Major responsibilities involved the required analytical testing for the release of Teva Products, solid dosage forms, blends, and raw materials.

Provided analytical support to the stability and reference standard departments.

Involved in the development of HPLC methods for the drug substance purity and the analysis of the finished product.

Provided management with GMP documented analytical methods, validation protocols, stability reports, standard operating procedures, and certificates of analysis.

Fort Dodge Animal Health, Princeton, NJ April 1996-October 2000

Analytical Chemist

Developed the optimum sample extraction procedure and gas chromatographic assay for the determination of drug potency in cattle ear tags.

Supported the clinical trials for the experimental ear tags by the sequential evaluation of clinical samples.

Extensively involved in the development, optimization and validation of HPLC and GC methods for several experimental formulations of different types of medicinal animal treatments such as de-worming pastes, pour-on, and injectable formulations.

Provided leadership as the laboratory safety coordinator for one year.

Wyeth-Ayerst, Princeton, NJ, September 1995- April 1996

Lab Support

Contract Chemist

Supported clinical studies for the drug metabolism department by performing complex sample preparations for the analysis of drug levels in human and monkey serum.

Education

B.A., Chemistry Temple University, Philadelphia, PA

Graduated Magna Cum Laude with an approximate GPA of 3.53

A.A.S., Medical Technology

Community College of Philadelphia, Philadelphia, PA

Graduated with high honors with an approximate GPA of 3.75.

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