Analytical Chemist R D

RESHMA DESAI

Phone: 847-***-**** Email: *********@*****.***, Location: Elgin, IL 60120

LinkedIn URL: https://www.linkedin.com/in/reshma-desai-04978a18a18

Scientist/Biologist/analytical chemist/research scientific associate

Highly motivated, detail oriented and experienced research and development scientist to join Bio/Pharma-Sciences group, have extensive experience (10+ Years) and proficient in all standard Bio/Pharma process technology. Assists in planning, development, and implementation of scientifically well-designed experimental programs (25+), lab testing coordination. With Strong Analytical, Technical, communicational skills and the ability to work independently and collaboratively in a multidisciplinary environment, looking to continue increase office efficiency, productivity, and quality for sustaining people’s lives.

Professional Experience

Baxter Pharmaceuticals R&D, IL

July 2022-Nov 2022 (Contract job)

Research Scientific Associate, Stability Lab

Conduct routine research and design experiments by working with colleagues to further technical understanding of related disciplines.

Conduct critical chemical, physical and biological analyses on finished product stability samples by following guidelines and directions, ensuring product samples meet appropriate standards.

Troubleshoot and resolve instrument problems by performing maintenance and calibrations as required so all equipment is performing as expected.

Conduct Analytical Testing (Wet Chemistry such as pH Determination, Conductivity, Lovibond Color-Colorimetry, Karl-Fisher Moisture Analysis, drying of reagents, Volumetric Transfer, UV Vis, HPLC using Chromatography Data System (CDS) Empower-3, etc.) for drug products, new product Development and/or Sustaining product Initiatives.

Short-Term and Long-Term Stability Studies, Short-Term Thawed State Stability Studies

Maintained data integrity and ensured compliance with company SOPs and specifications, FDA, cGxP and QSR regulations.

Performed review of test data, which includes overall documentation practices, review functions in LIMS or other computerized systems.

Performed advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles.

Performed equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.

Collaborated with other departments/functions to solve problems. Increase efficiency, improve quality, and provide product support.

Maintained laboratory supplies and laboratory safety requirements to always ensure audit readiness.

Mantrose - Haeuser Co., Inc., IL

April 2022-June 2022 (Contract job)

Food Science Associate/Quality Assurance Tech

Following FDA, GMP and SQF guidelines, Analytical Tests such as Viscosity (Cold and Hot), pH, Moisture, Bulk Density, Sieve test, Dispersion Test, ATP Swab test (Hygiena Quick Test), System Sure Plus Test (Swab Test), for Raw Food Materials, In-Process and Finished Products: such as different types of Gums (Guar, Xanthan, Tara, Gellan, Arabic, Acacia, Locust bean etc.), food preservatives, Emulsifiers and stabilizers etc.

Produced COA (Certificate of Analysis) for different Food Products

HACCP Certification from Online Alison Courses (May-2023)

Pfanstiehl Inc., Waukegan, IL

Oct 2021-Mar 2022 (Contract Job)

Analytical Chemist/QC Chemist (Scientist)

Drug/Drug Substances Manufacturing Company

Following USP, EP, JP, ChP Pharmaceutical Guidelines and GMP performed following Analytical Tests on Raw Materials, In-Process and Finish Products such as Sucrose, Galactose, Trehalose, Mannitol, Histidine, Arginine etc.

Color Value and Clarity of solution, ID (Cupric Tartrate, Infra-Red Spectrophotometric, IR), Water Determination by Volumetric Karl Fisher Titration, Conductivity, PH Determination of solution by Mettler Seven Excellence, Specific Rotation, Ultra Violet Spectrophotometer (UV-Vis), Dextrins, Reducing Sugars, Sulfites, Sulfates, ROI (Residue On Ignition), LOD (Loss On Drying), Calcium, Chloride, Assay Titration, Soluble Starch, Acidity of Solutions, Color of Solutions, Invert Sugars, Glucans, Endotoxins (LONZA) etc.

Trained in HPLC, ICP-MS, Elemental Impurities, Residual Solvents, TLC (Thin Layer Chromatography), TOC, LC-MS etc. Software: Empower

Pfizer, New Jersey (Remote)

May 2021–Aug 2021 (Contract Job)

Stability Specialist

Supports internal customers in the set up and change management of stability studies, fielding stability-related queries concerning marketed pharmaceutical products and active pharmaceutical ingredients and prepares submission-ready reports on stability data.

Works closely with manufacturing sites to ensure that all stability commitments are met including receipt and placement of stability log on condition.

Supports entry and administration of the Laboratory Information Management System (LIMS) where all stability data are stored including study creation, sample allocation and general system maintenance and change control.

Pull Analytical testing data from LIMS.

Pull data, data entry, report creation, data consolidation.

Formatting, proofing, and completion of Stability protocols, Stability study reports, summaries, and other related Stability documents.

Compile data into a report to submit for approval.

Ensure Compliance of Stability services with cGMPs, Corporate and Regulatory policies and guidelines

Provides regulatory document formatting support to the Stability Administration and Quality Assurance Teams, ensuring successful preparation of Internal and External Stability Report documents.

Imports and routes documents in the submission system (eDOCS).

Creates and updates Stability templates as directed by the Stability Admin Team.

Accurately and timely maintains document tracking for all documents.

Abbot Laboratories, Abbot Park, IL

Feb 2020–Feb 2021 and Feb 2014–Feb 2018

Biologist / Associate Scientist (Contract Job)

Medical/Scientific/Regulatory Affairs (Global Technical Support), IVDR (In-Vitro Diagnostic Regulation for European Commission): Design Verification and Validation Studies such as Reproducibility, Specimen On-board Study, Dilution Verification Study, if any discrepancy exits during studies, then Investigation report writings, also helped in Protocol and Product Requirement Document writing [Medical Devices worked on: Architect (Clinical Chemistry, Immunoassays) and Alinity]

Assist principal scientist with hands-on support of reconfiguration of calibrators using different substitute of proteins/surfactants and prepping different titrations of conjugate/tracer diluents etc.

Acquired a knowledge of Coating/co-coating of different monoclonal and/or polyclonal antibodies to different % solid microparticles to evaluate performance of the experiment by precision studies.

Research and Development (Companion Diagnostics) Dept.: Assay Development and Prototyping, Immunoassay developer Assistant (Product Development Assistant Scientist)

According to the principal scientist, Designs and conducts experiments, summarizes data, interprets, and draws conclusions and records the findings.

Evaluates data using analytical methodologies (Macro, JUMP) to achieve results. Recommends options for future experiments, presents scientific observations to a senior and/or Principal Scientist and/or team.

Responsible for project science within area of expertise on one or more project teams. Assays worked on: Free and Total T3, Free and Total T4, Rubella, Toxoplasma, CMV (congenital Diseases), Total PSA, Troponin, Methotrexate, LDH, Folate, Testosterone, Cortisol, Estradiol, BNP, CA 15-3, CA 19-9, HE4, AUSAB, CA 125 (Breast Cancer Marker), etc. on the Abbott ARCHITECT immunoassay system and Alinity.

Assist principal scientist with hands-on support of handling proteins (including purification), reconfiguration of conjugate solutions etc.

Performed methods such as SDS-PAGE (Gel Electrophoresis), Western Blot Etc.

Documentation of data in an Electronic Lab Notebook system (ELN-eNovator System) and/or PEAR data system. Appropriately documents experimental procedures and results according to established guidelines. Performs quality control studies to ensure accuracy of clinical data.

Expertise in Problem Solving: Identifies technical alternatives, anticipates, recognizes, and resolves technical problems. Prioritizes work based on departmental needs. Formulation and production of routine laboratory reagents and solutions.

Performed Characterization Study: Precision Study, Linearity Panel Prep. LOBDQ Panel prep, Within Assay Sample Carryover Study, Measuring System Analysis Study, On-Board Stability Study, Auto dilution Verification Study, Accuracy to World Health Organization (WHO) Standard, Sensitivity, Specificity, Interference study, Verification and validation study, Tube Type Matrix Comparison etc.

Knowledge and experience of ELISA Method from varieties of Immunoassays, have done manual ELISA Miro-plate technique.

Career Note: In between period gaps were due to either caring for family member, or moved to different locations, or working on further education.

Education & Professional Development

Diploma in Liquid Chromatography

Chicago Chromatography Discussion Group, Chicago, IL (May-2022)

Diploma in Biotechnology (Graduate Level)

Roosevelt University, Chicago, IL (May 2004-May 2006)

Bachelor of Science in General Science

Major-Biology, Medical Technology Minor: Cellular and Molecular Biology

Roosevelt University, Chicago, IL (May 2000-May 2004)

Bachelor of Science in Microbiology (Foreign Degree, Major-Microbiology, Minor-Botanical Science)

ASCP (American Society of Clinical Pathology) Board Certifications:

MT (Medical Technologist), MLS (Medical Laboratory Scientist), CLS (Clinical Laboratory Scientist)

School Internship:

Worked with Protein and Enzymes, DNA Extractions, Cell Cultures, Chromatography, NMRs, some experience with SDS PAGE and HPLC, good knowledge of Protein Structure, function, and purification. Experience in techniques such as ELISA, Western Blot, PCR Etc. Also have worked on small and large molecule drug development process.

Past Relevant Experiences

Position Title: Medical Technologist/Medical Lab Scientist/Clinical Lab Scientist (Details with exact time periods and companies will be available upon request)

ACL Lab (Advocate Health), Rosemont, IL

Instrument in use:

Architect i1000\i2000 SR- Immuno-Assay System

In-Vitro diagnosis of Vitamin D-(1, 25 Di-Hydroxy) with the instrument Liasion from Diasorin

IMMULITE 2000\2500 instrument for all types of Allergens

Accu-Lab Medical Testing, Chicago, IL (Contract based)

Medical Technologist- Drug of Abuse Testing for Urine Specimen -Toxicology

Drugs such as PCP, ETOH, COCAINE, METHADONE, OPIATES, THC, BENZ, BARB, PPX, ECTASY,

METHAQUALONE using ELISA method.

Instrument in use: OLYMPUS-AU 640

Children's Memorial Hospital, Chicago, IL

Shift Coordinator (Supervisor)

Monitors daily workflow, overseeing and adjusting staff assignments and priorities to meet service levels.

Performs technical review and interpretation, Troubleshoots, and solves problems:

Recognizes test system performance problems and takes necessary corrective actions.

Recognizes when unresolved problems need to be escalated and takes necessary follow-up action.

Prints pending logs and follows-up to ensure pending tests are completed or cancelled when appropriate.

Instrument utilized Includes:

Advia Centaur, Stago-Evol, Clinitek, UniCel-DXC-600, BecT-Alert, Nova, TDX, UniCel DXC 600(Beckman Coulter)

Dept; CHEM: Dimension, Centaur, Vista HEMO: Sysmex-XE-2100, XT-1800i, COAG: STAgo, Sysmex-CA 1500, URINALYSIS: Iris-IQ200, Acess2, Urine and serum osmolality,

Blood Gas: instrument in use: RapidPoint 405(Bayer), HCG-pregnancy (serum and urine) test (Quick Vue), Dept: Hemo: instrument in use: XT Sysmex 2000i/1800i

Manual differential (Cell identification, WBC, RBC, WBC’s and RBC’s inclusion Bodies, correction for NRBC, Platelet Estimation, manual cell counts etc., other instrument in use: Hema-Tek 2000 (Blood Smear Slide Stainer), Biosite Triage Meter (for BNP test)

Rapid Test Kit: Directigen EZ: Strep A, Flu A&B, ROTA Virus, RSV and Rapid C. Diff. Toxins A & B (Micro Test). Dept: Coag: instrument in use: ACL 8000: test: PT/INR, PTT, FDP, D-Dimer, Fibrinogen, Hepcheck etc.

Blood Bank: Instrument in use: MTS Gel System: Test: Antigen type and Antibody screening, cross matching, platelet apheresis etc.

Dept.-Immunology-Test HIV-1 type antibody from dry blood spot and same with HCV test by ELISA method (enzyme-linked immunosorbent assay or EIA), performed manual microplate washing, spectrophotometer use, strong pipetting skills, staining, Confirmation test for HIV-1 and HCV with IFA and RIBA methods accordingly.

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