Quality Control Research Scientist

LAMONT S. SMITH

*** *. **** **** ***** Lake, IL *0073-8162

224-***-**** ********@*****.***

Summary of Qualifications:

Extensive background as an Analytical Chemist with over 20 years of pharmaceutical experience in Quality Control, Research & Development, and Radiopharmaceutical testing for Positron Emission Tomography (PET).

Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices, FDA and U.S.Pharmacopeia (USP) experience, solid organizational and laboratory skills including Method Validation testing on HPLC, documentation experience including review and updating SOPs and Analytical Chemistry Reports.

Experience with Inductively Coupled Plasma - Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) while at AbbVie.

Experience with HPLC (Agilent with ChemStation software, Waters Alliance with EMPOWER software), Gas Chromatography, UV/Vis Spectroscopy, IR Spectrometry, Thin-Layer Chromatography, Karl Fischer Moisture Determination, Dissolution testing and HIAC 8000A Particulate Matter Instrumentation.

Experience with laboratory procedures, radiochemistry techniques and analytical method equipment (ICP-MS, ICP-OES, HPLC, GC, TLC, and radiometric measures) while at IBA-MOLECULAR and AbbVie.

Demonstrate strong problem solving and analytical skills.

Analyzed trending data results utilizing critical thinking skills, organized data and prepared documentation with minimal guidance at Catalent Pharma and Sovereign Pharmaceuticals.

Biochemistry lab testing experience as a Medical Laboratory Specialist in the U.S. Army.

Very self-motivated, with a strong work ethic and attention to detail in a fast-paced environment.

Perform under pressure to meet project deadlines.

PROFESSIONAL EXPERIENCE:

Procter & Gamble (Infotree Global) North Chicago, IL Mar. 2025 – Present

Analytical Chemist

-Analytical testing on raw material ingredients used in household products such as antiperspirants, dishwashing liquids, vapor rubs, etc.to meet FDA Regulations.

-Testing includes chemicals such as Aluminum, Zirconium, Chlorides pH, Conductivity, Titration Assays, HPLC Assays and various wet chemistry procedures.

- Current GMP, GLP and Good Documentation Practice.

-Instrumentation includes Thermo Scientific ICP-OES (Inductively Coupled Plasma - Optical Emission Spectrometry). and Agilent 1200 HPLC.

ABBOTT CORE Diagnostics (SpectraForce) Lake Forest, IL Jan. 2021 – Dec. 2024

Technical Support Scientist IV

-Responsible for transitioning from IVDD (In-Vitro Diagnostic Device Directive) to IVDR (In-Vitro Diagnostic Device Regulations) compliance for ~200 products.

-Provide technical input as Subject Matter Expert (SME), review/verifying Technical Files including Lookback Memos for verification, redlining labels such as Information For Use (IFU), kits, vial labels, performing article searches for product verification in the bibliography of IFU’s, conducting and verifying information for Performance Evaluation (Procedures, Reports), Antigen-Antibody, Component Composition, Address of Manufacture/Manufacturing Testing Outline, and Raw Materials Sources and Specifications.

AbbVie (Pro-Clinical Staffing) Abbott Park, Lake County, IL May 2020 – Nov. 2020

Chemist III

- Provided technical support using analytical instrumentation such as ICP-MS (Inductively Coupled Plasma - Mass Spectrometry) and ICP-OES (Inductively Coupled Plasma Optical Emission Spectrometry).

- Performed Drug Substance and Drug Product characterization for Elemental Impurities sample testing on Active Pharmaceutical Ingredients (API).

-Instrumentation included Perkin-Elmer 350D ICP-MS and Perkin-Elmer 8300 ICP-OES

DC TRICORE, Inc. Waukegan, IL Aug. 2019 – Feb. 2020

Analytical Chemist

- On a daily basis, oversaw and performed Quality Control testing of precious metals in an Analytical Chemistry testing laboratory for elements such as Platinum, Palladium and Rhodium in automotive catalytic converters efficiently and quickly.

-Communicated with upper management and provided scientific data that the business owners were able to use effectively in making important decisions affecting the company.

-Instrumentation included Rigaku Energy-Dispersive X-ray Fluorescence Spectroscopy and Agilent ICP-OES (Inductively Coupled Plasma - Optical Emission Spectrometry).

Becton, Dickinson and Company (BD-CareFusion)Vernon Hills, IL Aug. 2017 – Jan. 2019

Scientist I, Research & Development

-Performed stability testing at different timepoints for ChloraPrep and Prevail-FX Applicators used for surgical skin disinfectants.

-Performed feasibility experimental studies to determine the outcome of various products under review by altering one component of study while the remaining components were kept constant.

-Instrumentation included Agilent 7890 (Gas Chromatography), Agilent 1100 and 1200 Series (HPLC) using Agilent ChemStation OpenLab software. MiniTab18 experience.

WEIMAN PRODUCTS, LLC Gurnee, IL Oct. 2015 – Mar. 2016

Interim Research & Development Chemist

-Formulated Batches on a low-scale basis (500 – 8000 grams) for low suds, low-cost, high-foam enzymatic detergents and spray gels.

-Performed stability studies on household products such as Toilet Bowl Cleaners, Garbage Odor Removers, Wipe Evaporation Rates (including Cook Top, Stainless Steel, Leather, Electronic and Granite wipes); Material Compatibility with solution stability, Foam and Color stabilities.

Baxter Healthcare Technology Park, Round Lake, IL Oct. 2014 – April 2015

Research Associate I

- IV Solution stability testing under normal and stress conditions while following Study Protocol.

-Testing included pH, osmolality, Particulate Matter of Stability samples, UV-Vis spectroscopy and Assay Titration testing. Current GMP, GLP and Good Documentation Practice.

-Instrumentation included Varian Cary 4000 UV-Vis Spectrometer and HIAC 8000A Particulate Matter.

Navy Drug Screening Laboratory-Great Lakes North Chicago, IL Jan. 2014 – May 2014

Analytical Chemist

-Prepared certified pure drug Standard and Control solutions for both military Initial Testing (immunoassays) and Confirmation Testing (GC/MS) to detect drug components such as opiates and amphetamines within patient samples while maintaining written documentation and electronic records. Current GMP, GLP and Good Documentation Practice.

-Reviewed and evaluated specimen immunoassay and GC/MS data in LIMS (Laboratory Information Management System), ensuring that all appropriate testing was completed in a timely manner.

NNE/HOSPIRA PHARMACEUTICALS Lake Forest, IL Mar 2013 – Oct.2013

Gap Analysis Analyst

-Performed gap assessment of method validations for HPLC, GC, UV/Vis, Infrared Spectroscopy, titration assays and other analytical validation methods.

-Evaluated test method validations against internal procedures, industry standards and regulatory agency requirements including USP.

- Reviewed analytical chemistry protocols and analytical test methods of final product release while collating the information to perform gap analysis of the release and stability testing for a large number of products.

IBA – MOLECULAR Dallas, TX Sept. 2011 – Mar. 2013

Analytical Chemist

- QC testing of PET (Positron Emission Tomography) Radiopharmaceutical finished products used in cancer diagnosis utilizing isotopes such as Fluorine-18 and tracers such as Fluorodeoxyglucose in the Nuclear Medicine industry. Current GMP, GLP and Good Documentation Practice.

-Testing consisted of Bacterial Endotoxin LAL using PTS reader, Thin-Layer Chromatography (TLC), Radio Nuclidic Purity By Gamma Spectroscopy using MCA scanner, determination of residual solvents using gas chromatography and calculating Radio Nuclidic Identity By Half-Life.

-Performed HPLC instrument validation/sample testing for Radio Chemical Identity. OQ and PQ (Operational Qualification and Performance Qualification) performed.

-Instrumentation included Agilent 6850 (GC), Agilent 1200 (HPLC), EndoSafe PTS Reader, BioScan TLC Scanner and Canberra MCA Scanner.

SOVEREIGN PHARMACEUTICALS, LLC Fort Worth, TX Sept. 2010 – Aug. 2011

Analytical Chemist II

-Q.C. Analytical testing of solid oral dosage tablets and capsules on Finished Product and Stability samples. Current GMP, GLP and Good Documentation Practice.

-Testing involved Dissolution, Assay and Content Uniformity using HPLC or UV-Visible Spectroscopy analysis.

-Instrumentation involved Varian Cary 100 Bio UV-Visible Spectrophotometer and Waters Alliance HPLC 2695 (2487 Dual Absorbance Detector) using Empower Software. HPLC Troubleshooting.

CATALENT PHARMA SOLUTIONS Woodstock, IL July 2009 – Aug. 2010

Analytical Chemist

-Analytical testing on Finished Products, Bulk Release and 1st Acceptable manufacturing pharmaceutical sterile solutions.

-Testing included pH, Conductivity, Osmolality, Titration Assays, Validation studies, HPLC Assays and various wet chemistry procedures.

- Current GMP, GLP and Good Documentation Practice.

-Instrumentation included Agilent 8453 UV-Visible Spectroscopy, Agilent HPLC (1200 Series using ChemStation software), Autotitrator (Mettler DL55), Osmometer, Horiba Particle Analyzer and Density Meter (Mettler DE50)

ABBOTT LABORATORIES North Chicago, IL April 2006 – Oct. 2008

Analytical Chemist II

-Dissolution of oral dosage medications such as antibiotics and antacids.

-Testing also involved pH, Karl Fischer Moisture and Thin-Layer Chromatography.

-Instrumentation included Agilent 8453 UV-Visible Spectroscopy, Training on HPLC Waters Alliance using Peak-Pro Software.

APOTEX CORP. Lincolnshire, IL May 2002 – June 2005

Scientist I

-Performed pharmaceutical stability study analysis on injectable Finished Products (syringes).

-Testing included pH Determination, Color Measurement, Force Determination on syringe plungers, Iodide testing, Osmolality and Assay Determination using. Agilent HPLC.

-Performed Analytical Method Validation testing on Agilent HPLC so that the instrument would provide reproducible, reliable and consistent results while performing daily HPLC testing on the liquid injectable test samples. Validation parameters tested which followed FDA and ICH guidelines included Accuracy, Linearity, Range, Precision (Repeatability, Intermediate Precision and Reproducibility), Specificity, Detection Limit (LOD), Quantitation Limit (LOQ), Robustness and System Suitability.

-Instrumentation included IR, UV/Vis Spectroscopy, HPLC (ChemStation software) and GC. Current GMP, GLP and Good Documentation Practice.

-Documentation writing experience such as SOP’s and Analytical Reports.

ABBOTT LABORATORIES Abbott Park, IL April 1992 – Nov. 1998

Quality Support Specialist / Q.C. Chemist

-Responsibilities included quality performance of final Master Lot release testing.

-Performed Enzyme Immunoassays (ELISA) on Abbott’s COMMANDER instrument such Hepatitis B Surface Antigen, HIV-1/ HIV-2 antibodies and HCV (Hepatitis C Virus).

-Human Leukocyte Antigen typing.

-Determination of antibodies using Flow Cytometer.

-Separation and purification of whole blood for lymphocyte isolation and freezing.

MILITARY EXPERIENCE: U.S. ARMY Medical Laboratory Specialist 1979 – 1985

EDUCATION: NORTHEASTERN ILLINOIS UNIVERSITY

Bachelor of Science, Chemistry 1991

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