THOMAS B. CZAJKOWSKI

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

Bloomingdale, New Jersey 07403

973-***-****/ adf7yp@r.postjobfree.com

Analytical Chemist with extensive and diverse experience in the pharmaceutical, biotechnology, cosmetic, specialty chemical, filtration, chromatography and environmental industries. Performed a wide variety of chemical analyses with an emphasis in the instrumental area. Skilled at all types of method development and validation for generic pharmaceuticals, biopharmaceuticals and proteins, following cGMP and ICH regulations. Supervisory experience. QA experience in data review and data integrity auditing, notebook auditing and Elemental Impurity risk assessment. Continuously demonstrated an ability to complete projects and assignments in a timely, creative and cost effective manner.

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

RUTGERS UNIVERSITY, B.S. Chemistry

Coursera/Johns Hopkins University COVID-19 Contact Tracing Certificate

INSTRUMENTATION

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

CONTINUING EDUCATION

Trained as an ISO 9001 Auditor, HPLC Method Development Presented by L. Synder

Varian/Vankel Dissolution Training Course

CAREER HISTORY

Consultant for NSF in New Jersey 5/2018 to 12/2019

Reviewed HPLC trial injections before analyses results for any evidence of sample injections.

Reviewed Test Methods for conformance to scientific principals.

Reviewed Test Methods for compliance to ICH, USP and cGMP guidelines.

Reviewed Notebooks for Validation and Stability results for Test Procedure, Protocol, calculation accuracy and compliance to cGMP regulations.

Reviewed Notebook HPLC data for accuracy and audit trails.

Consultant at Par Pharmaceutical 11/2017 to 5/2018

Reviewed IQ, PQ and OQ, calibrations of HPLC, Dissolution Apparatus, Spectrophotometers and ICP instrumentation as a QA consultant.

Reviewed Test Method validation protocols and reports for HPLC, ICP and GC instruments.

Performed Elemental Impurity Risk Assessments for Raw Materials, Excipients and Finished Products.

Consultant through ALKU for Cook Pharmacia in Bloomington, Indiana 10/2016 to 08/04/17

Scientist implementing and executing methods transfer for peptides, antibody and polysorbate using ion exchange, size exclusion, and reverse phase chromatography. Performed peptide mapping and A280 analysis. Trained on PCR and capillary electrophoresis.

Reviewed protocols, transferred method into the Cook format, executed protocol by performing the bench work in the laboratory and wrote summary report.

Consultant through Validant for Patheon in Italy 03/2016 to 08/2016

Subject Matter Expert: Reviewed Test Reports for Assay, Impurity and Identity procedures for Patheon Products and raw materials for compliance to SOP, USP, cGMP and ICH guidelines. Analyses included, HPLC, GC, IR, UV/Vis test methods. Issued non compliance reports for any deficiencies found.

Managed and coordinated with Patheon the workflow of the audits for the department

Consultant through Validant for Impax in San Francisco 05/2013 to 12/2015

Test Method remediation to resolve a warning letter from the FDA.

Performed Gap Analysis on current Test Method validations and identified deficiencies in conforming to ICH guidelines and the USP.

Wrote validation and verification protocols to correct the deficiencies in the validation of the Test Methods.

Thomas B. Czajkowski 973-***-**** adf7yp@r.postjobfree.com Page 2

Reports and Protocols written for Assay, Related Compounds, Dissolution. Identity and Residual Solvents test methods for Solid Dosage Forms, Drug Substances, Tablets, Capsules and Excipients.

Troubleshooting of problems that occurred during the execution of the protocol

Wrote concluding report after protocol execution.

As a result of the remediation the FDA lifted the warning letter for Impax.

Technical Services

·Interacting with suppliers for the purpose of updating Test Methods and Specifications.

· Creating Specifications for new products.

· Evaluating and Updating Specifications for gaps in Testing Methods.

· Updating Methods and Specifications for changes in USP monographs.

UNIGENE Laboratories, Boonton, NJ Reason for leaving: 40% staff reduction 11/2011 to 04/2013

Senior Product Development Scientist

Method Development and Validation of Cleaning Methods for several Peptide drugs and Proteins.

Proficient in HPLC data acquisition software with audit trail.

Assay and Dissolution analysis of Stability Samples for Peptide Drug tablets.

Method Development and Validation for surfactants and actives in tablet drug products.

HPLC troubleshooting, maintenance, calibration and repair.

Size Exclusion Method Development and Validation for aggregates of a Peptide Drug.

ASCEND Laboratories, Fairfield NJ Reason for leaving: company closed 01/2006 to 11/2011

Senior Scientist

Method Development and Validation 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.

Instrument maintenance, troubleshooting and calibration.

Trained and mentored junior staff members.

Proficient in Empower HPLC data acquisition software with audit trail.

PFIZER, Morris Plains, NJ 04/2005 to 01/2006

Associate Scientist

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

PLIVA Inc, East Hanover, NJ, Reason for leaving department: closed 07/2002 to 04/2005

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.

Analyzed cleaning validation samples.

As supervisor designee, trained and mentored junior staff and 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%.

Administrator for Empower Chromatographic Software with data trail.

LIPO CHEMICALS, Paterson, NJ 01/2000 to 07/2002

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.

WHATMAN Inc., Clifton, NJ. Reason for leaving: department closed 02/1992 to 12/2000

Staff Scientist

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

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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