Karen E. Kaikaris

***** **** **.

Oak Forest, IL 60452

708-***-**** 312-***-**** mobile

adapf9@r.postjobfree.com

Objectives

To continue my career that helps use/develop/expand my work experience in an aggressive company that will help me develop, grow solve your problems, and cut costs to streamline your company needs into the future.

To assist with method development, validation of methods, process improvement and troubleshooting, protocol creation, execution, and final report generation to grow with the modernization of company needs following cGMP SOP using my various instrumentation experience with various dosage formulations (solid/liquid/lyophilized and more).

Work Experience

Regis Technology-Consultant (November 2016-March 5, 2017)

(March 6, 2017- Nov2018)Analytical Chemist II in Analytical (Method) Development/Analytical Development

Preparation of analytical method for various drug substances and drug products using various Chromatography methods using Chromeleon software (HPLC, GC), evaluating, developing and validation of methodology.

Preparation of protocols and reports for validation needs.

Degradation studies of both light and chemical (acid/base peroxide)and freeze/thaw studies.

Karl Fisher experience.

TGA experience

Writing of documents for SOP wide variety of developed methodology.

Involved in creation of method transfers work(protocol/performance of protocol/creation ofreport)

Maintenance ad yearly scheduling of light stability chamber (Atlas).

Monthly maintenance of HPLC systems and yearly IQ/OQ/PV.

Save over $30,000 in budget for supplies for instruments and consumables for facility.

CWC Laboratories-Consultant-Austin, TX (June-July 2016)-LC/MS (TOF) Chemist

Preparation of Quencher technology for food additive testing for trace pesticides.

Method development for pesticides and cannabinoids in hemp oil using both positive and negative mode.

Analysis using the Agilent pesticide and forensic toxicology PCDL on an Agilent Time of Flight accurate mass system, resulting in AOAC poster entitled An LC-MS-TOF Method for Quantifying Components of Interest in Hemp Extract.

Responsible for instrument troubleshooting and preventative maintenance, developing SOPs, and assisting in ISO certification.

Universal Consulting Services-Consultant-Great Lakes Naval Drug Screening Laboratory-(March 2016-June 2016)-LC/MS/MS/MS Chemist

Preparation and analysis confirmation of controlled drugs in urine samples using both GCMS and LCMSMSMS (triple Quad).

Maintain 3 LCMSMS systems- Agilent 6460 with 1290 UPLC systems with nitrogen genrators.

Messina Group Inc-Consultant- Fresinius Kabi (November 2015 till March 2016)-Sr QA (Quality Assurance) Specialist

Audit of Exhibition batches and Freeze/Thaw protocols/reports including reports from instruments of HPLC, GC, MS, TLC, IR, UV/VIS, NMR, AA, dissolution, KF, UV, IR, Potentiometric titration, and wet chemistry techniques.

Extensive knowledge of cGMP and GLP and 21 CFRPart 210 and 211.

Quality audit of QC and microbiology laboratories.

Review of production batches.

Creation of SOPs and other procedures for cGMP work.

Texas A&M - Consultant- Corpus Christi, TX – Center for Coastal Studies (2015) Research Scientist

Novel plant discovery, toxin fractionation and natural product characterizaton of sea algae.

Toxicology screening using Time of Flight (TOF) LCMS.

Quantitation of toxins using triple- and single- quadrupole LCMS.

Toxicology screening using Time of Flight (TOF) LCMS.Creation of custom natural product libraries.

Hiregenics-Consultant - Baxter - Round Lake, IL (Jun2014-July 2015) Research Scientist II- main work with Carrera Project

Analytical support for product line development/support. Support of methods using cGMP and GLP protocol for all products under Carrera Project both as Active Pharmaceutical Products (API) and finished products as well as intermediate stages of development.

Perform HPLC analysis, Osmolality, pH, Color, UV Scan, TLC, IR, UV/VIS, NMR, AA, dissolution, KF, Potentiometric titration, and Visual Inspection, and other wet chemistry techniques on development and stability batches.

Nu-Co-(HPD)/Hospira (2003-2014)

Research Chemist - Chemical Method Validation Group/Lab Leader/Control Drug Agent (2003 - 2014) Pharmacist/Chemist (2008 - 2014)

Analytical support for product line development/support/alternate API suppliers using appropriate scientific technique. Development, validation, and support of methods using cGMP and GLP protocol for all products.

Final writing for SOP and methods for production and characterization of final drug substance and drug product release.

Prepare analytical reports of data and contributions of other technical documents. Follow 21 CFR Part 11 procedures and perform functions to help maintain the safety and efficacy of drug products using FDA guidelines as well as EP/USP/BP/JP and other guidelines.

Involved with qualifying alternate suppliers and stability batches from starting comparison reporting to CTD creation for submission to FDA for both Drug Substance and Drug Product.

Evaluate the current marketed drugs for meeting current ICH/FDA and Corporate Validation Requirements.

Generating the necessary protocol/reports for method development, method validation, and stability as well as GAP assessments. Updating documents up to current regulation standards.

Lab leader for the area to monitor and ensure compliance with all regulatory (FDA, EMEA, HPB, TGA, e.t.c.) requirements and corporate, compendial (EP/USP/BP/JP) and ICH guidelines.

Perform HPLC analysis, Osmolality, pH, Color, UV Scan, TLC, IR, UV/VIS, NMR, AA, dissolution, KF, Potentiometric titration, and Visual Inspection, and other wet chemistry techniques.

G.D.Searle-Monsanto-Pharmacia-Pfizer (1997-2003)

Research Chemist (Analytical Services)/Development Chemist-Dosage Formulation

Analytical and technical support for product line development using appropriate scientific technique- GC, HPLC, UV, and other instrumentation throughout the corporation.

Helping keep product lines up to current cGMP standards for validation requirements with current FDA/ICH guidelines.

Development, validation, and support of methods using GMP and GLP protocol for new products (Using both API and finished formulation or finished product) and on market products and generating the appropriate protocols and reports and updating internal corporate documents.

Responsible for operating, troubleshooting, and maintaining instrumentation. Prepare analytical reports of data and contributions of other technical documents for product integrity (IQ/OQ/PQ).

Sandoz Agro –Consultant-(1996)-Temporary Scientist

Determination of pesticide residue in various agricultural products.

Assist dismantling and transition of laboratory to out of state.

Stat Analysis Corporation (1994-1996) Senior Analytical Chemist

Performance of volatile organics, and acting backup for semi-volatile and PCB/Pesticide, metal analyses using EPA methodology. Assist with the management of samples and reporting of the analytical data to clients.

Maintenance of the GC/MS systems and purge and traps for EPA methodology 8260 and 8270.

Chemical Waste Management (1984-1994) Analytical Chemist

Performed volatile organic, semi-volatile, PCBs, solvent screen, pesticide, and industrial hygiene analyses following the Method 8800/8260/ 8270/8080 and more.

Interpreted chromatograms, generated reports, maintained instruments and service records, calibrated test equipment and performed QC analysis.

Supervised lab technicians, trained employees in PCBs, solvent screens and industrial hygiene.

Acted as lab safety monitor.

Developed methods to analyze various chemicals in different matrices using GC (FID, ECD, NPD, and MS), HPLC (UV-DAD) and UV-VIS.

Maintained PAT-NIOSH certification for Industrial Hygiene for the corporation.

Maintain the ECD Nickel certification.

Helene Curtis Industries (1983-1984) Research Technician

Developed methods for analysis of perfumes, surfactants and preservatives using GC and HPLC systems.

Competitive product analysis activity.

Education

Temple University - School of Pharmacy - Philadelphia, Pennsylvania (May 2002)

Masters in Quality Assurance/Regulatory Affairs in the Pharmaceutical Industry

Temple University - School of Pharmacy - Philadelphia, Pennsylvania (December 2000)

Basic Certificate in Pharmaceutical Studies

University of Illinois - Urbana-Champaign, IL (May 1982)

Bachelor of Science in Chemistry and Biochemistry, Minor in Physics and Mathematics

IIT Graduate work - Chicago, IL (1982-1983)

Additional Technical Training

Agilent Technologies – Single Quadrupole LCMS Training

Agilent Technologies – LCMS Time of Flight Training

Agilent Technologies – Triple Quadrupole LCMS Training

Proficiency in Instrumentation, LIM Systems, and Software

Agilent/ GC/MS (Target Unix, Chemstation/Chemstore, and Mass Hunter)

Agilent GC (7890, 6890, 5880, 5890 with FID, ECD, NPD, FPD), Purge and Trap (Tekmar and O/I), and HPLC (HP1260, 1290, 1100, 1050, and 1090)

Waters Alliance/Empower/Millenium, Acquity, and 2695.

Familiarity with programs for data collection Atlas, Empower, NuGenesis, Chromeleon, OpenLab, and more.

Use of Electronic Notebook (Accelrys/Symyx)

Routine software such as Microsoft Word/ Excel/PowerPoint, MassHunter, Chemstation/Chemstore, and Millenium/ Empower, Chromeleon, SAP, Citrix.

Working with solid/liquid/lyophilized dosage formulation as drug substance and drug products.

Working with creation of formal documentation to prepare SOP and final methodology for submission in final CTD documentation and other GMP formats.

Professional Societies

American Chemical Society (ACS)

American Association for Pharmaceutical Scientists (AAPS)

Chicago Chromatography Discussion Group (CCDG)

Publications/Posters

Analysis of Non-Volatile Congeners in Spirits by Creation of an Ion Fragmentation Database for Use with Time of Flight LCMS, with Susan D’Antonio, Rita Steed, Joan Stevens, Lynne Marshall and Karen Kaikaris presented at PittCon 2016, session 1350; Food Product Quality and Component Characterization II

Analysis of CBD in Hemp oil using TOF-LCMS-poster submitted in AOAC Meeting September 2016 with Mike Adams, Susan D’Antonio, Rita Steed, Joan Stevens, and Karen Kaikaris at PittConn March 2017 and ASMS presentation June 2017 and HPLC2018 Conference.

Characterization of Hazardous Waste Solvents by Capillary Gas Chromatography, John Krecisz, Carol Chow, and Karen Kaikaris, Midwest AOAC meeting

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