Analytical Chemist Raw Materials
Resume:
Carole Bodziuch
Riegelsville, PA 18077
Home: 610-***-****
Cell 610-***-****
**************@*****.***
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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