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Development Plant

Location:
Bloomingdale, NJ, 07403
Posted:
August 08, 2012

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Resume:

THOMAS B. CZAJKOWSKI

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

Bloomingdale, New Jersey 07403

973-***-****/ ldzy35@r.postjobfree.com

Analytical Chemist with extensive and diverse experience in the pharmaceutical, cosmetic, specialty chemical, filtration, chromatography and environmental industries. Performed a wide variety of chemical analyses with an emphasis in the instrumental area. Skilled at directing environmental and industrial hygiene regulatory compliance programs. Continuously demonstrated an ability to complete projects and assignments in a timely, creative and cost effective manner.

CAREER HISTORY

UNIGENE Laboratories, Boonton, NJ 2011 to Present

Senior Product Development Scientist

• Assay and Dissolution analysis of Stability Samples for a tablet containing a Peptide Drug.

• Method development for a surfactant in a tablet drug product.

• Instrument troubleshooting and repair.

• Size Exclusion Method Development for aggregates of a Peptide Drug.

ASCEND Laboratories, Fairfield NJ 2006 to 2011

Senior Scientist

• Method Development for Assay, Related Compounds, Dissolution, and Cleaning Validation of Generic Drug Products from researching methods to bench work.

• Method Validation Protocol writing, execution, and Report writing for Assay, Related Compounds, Dissolution and Cleaning Validation of Generic Drug Products.

• General Lab administration: sample tracking, supplies ordering and administering hazardous waste disposal program.

• Instrument maintenance, troubleshooting and calibration.

• Stability Sample analysis and summary report writing.

• Creating SOP’s to set up a new CGMP laboratory.

PFIZER, Morris Plains, NJ 2005 to 2006

Associate Scientist

Associate Scientist in Central Stability Laboratories, performing test methods for Assay, Impurities, and Dissolution using HPLC instrumentation.

PLIVA Inc, East Hanover, NJ 2002 to 2005

Scientist

Scientist for Global Analytical R&D. Performed method development, method protocol and report writing, work scheduling, investigations and general procedures.

• Developed, wrote protocol, executed and wrote validation report for Cleaning Methods.

• As supervisor designee, conducted Investigations and wrote reports for OOS results.

• Performed stability analyses and documentation work for 3 ANDA submissions in 6 months as a member of a team, after the staff was reduced by 75%.

• Wrote and executed IQ and PQ protocols for Laboratory equipment.

• Administrator for Empower Chromatographic Software.

Thomas B. Czajkowski 973-***-**** ldzy35@r.postjobfree.com Page 2

LIPO CHEMICALS, Paterson, NJ 2000 to 2002

Analytical Chemist

• Performed, developed and validated GC, HPLC, FTIR, UV/Vis, TLC and wet chemical Q/C analyses of raw materials, research projects and products related to the cosmetic, and personal care industry.

• Wrote SOP’s for calibration of HPLC, UV/Vis, FTIR, and GC instruments and set up a calibration program.

WHATMAN Inc., Clifton, NJ 1992 to 2000

Staff Scientist

Sole analytical chemist in engineering department

• Provided technical and manufacturing support and testing on teams that developed novel filtration devices.

• Project leader and developer of a filtration/extraction device written into a United States Department of Soil Conservation analytical method.

• Developed over 100 applications for Whatman HPLC columns.

• Assisted customers in developing and/or improving their HPLC and SPE analysis methods.

• Evaluated customer complaints and problem troubleshooting for Filtration Devices, HPLC Columns, and Solid Phase Extraction Devices.

• Presented two papers at Pittcon on topics related to HPLC and microfiltration, and gave presentations on company products to customers and sales representatives.

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WARNER-LAMBERT, PARKE DAVIS, Morris Plains, NJ 1990 to 1992

Associate Scientist

Performed HPLC method development and validation for assay, content uniformity, dissolution and stability analyses on liquid and solid dosage forms for NDA submissions and clinical trial samples. Administrated and maintained the reference standard storage program for department.

DREW CHEMICAL CORPORATION, Boonton, NJ 1987 to 1990

Chemist

Analyzed a wide variety of solid and water samples, products and raw materials pertaining to the cooling and boiler water treatment industry using classical (titration, solvent extraction) and instrumental methods.

ICM LABORATORIES, Randolph, NJ 1986 to 1987

Chemist

Performed Gas Chromatographic Analysis of PCB's and Pesticides in soil and water samples according to EPA methods in an EPA certified laboratory.

BASF/INMONT, Hawthorne, NJ 1977 to 1986

Chemist/Plant Health Contact

Performed instrumental analysis on raw materials, pigments and flushed bases (inks) for PCB,s and 3,3 dichlorobenzidine. Supervised an employee chemical exposure monitoring program for a suspected carcinogen 3,3 dichlorobenzidineused in the plant. Participated in OSHA audits.

Directed monitoring programs for the EPA and Passaic Valley Sewer Authority permit for plant effluent water streams. Participated in EPA audits.

INSTRUMENTATION

HPLC: Shimadzu, Waters, Agilient with UV/Vis, Diode Array, Electrochemical, Conductivity, and Refractive Index Detectors, GC: Agilent, Perkin Elmer, GC/MS: Thermo FTIR: Perkin Elmer, Nicolet, X-Ray Fluorescence, X-Ray Diffraction, Atomic Absorption, Solid Phase Microextraction, Chromatographic Software: Waters Millenium and Empower, Beckman Peak Pro, Turbochrom and Agilient Chemstation, Agilient UV/Vis automated dissolution system, VanKel and Distek dissolution baths, Vankel Automated Dissolution Sampling System, VanKel Bio Dissolution System

EDUCATION SETON HALL UNIVERSITY MS, 2001, with Thesis in Chemistry, GPA 3.8

RUTGERS UNIVERSITY, B.S. Chemistry,

CONTINUING EDUCATION

Trained as an ISO 9001 Auditor

HPLC Method Development Given by L. Synder.

Varian/Vankel Dissolution Training Course

Industrial Hygiene Training Course



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