Madhura M Sagare

Burlington, MA

Email: ad1r36@r.postjobfree.com

Ph: 972-***-****

PROFESSIONAL SUMMARY:

Dedicated and accomplished Quality Control specialist with 8 years of hands-on experience of sample management, analytical and molecular testing of samples for raw materials, in-process samples, and finished products across diverse platforms.

SKILLS:

Technical Skills: HPLC, ELISA, LIMS, Western Blot, BCA assay, SDS-Page Gel Electrophoresis, FTIR, Capillary Electrophoresis, Bioburden, Conductivity TOC, Endotoxin, pH

Computer Skills: Open Lab, SoftMax Pro, Lab Vantage, Quantasoft, Sciex 32 Karat, Data-Pro, Endocan, LIMS Sample manager, LIMS, Veeva, QMS

PROJECTS:

1.University of Houston, Clear Lake, Coral Genomics: (March 2012- Dec 2012)

Work involved handling prostaglandin standard samples and passing them through liquid chromatography mass spectrometry (LC-MS). Extracting prostaglandins from the coral Plexaura homomalla and checking its presence by running it on LC-MS.

Carrying out Capillary Electrophoresis used for DNA fingerprinting in the cDNA libraries.

Studied the different rates leading to separation of prostaglandins by carrying out SDS-PAGE

2.University of Houston Clear Lake, Nitric oxide Synthesis: Performing Co-IP Assays to confirm the protein- protein interaction shown by the yeast two hybrid technique. Work was done on the cDNA libraries of human testis screened proteins.

3.Cell and Molecular Biology Lab- Jun 2008 – Feb 2012: Microbial Production of Omega-3 Fatty acid

DNA, RNA isolation from fungal cultures like Mucor plumbeus, Mucor species and Mucor

hiemalis. Using pet-Easy Vector (Promega) System for cloning of PCR products

Worked with pYES Vector System (Invitrogen) for Yeast Transformation.

Bacterial and Yeast Transformation on the Eppendorf Multiporator Electroporator

4.Animal Tissue Culture (Jun 2007-May 2008):

Cultured and Harvested Vero Cell Line in EMEM media.

Growth of (OPV)(Oral Polio Vaccine) Polio Virus Strains 1,2 and 3 (Obtained from Enterovirus Research Center, Indian Council of Medical Research, Mumbai, India)

TCID50 (Tissue Culture Infective Dose) of each virus strain, Neutralizing Antibody

Titre Assay for serum of children (9-24 months)

WORK EXPERIENCE:

Oxford Biomedica Solutions, Bedford, MA

Quality Control Analyst

Jul 2021-Present

Involved in Method Validation -Fit for Purpose experiments and Method Qualification for new lot of testing materials.

Involved in Enabling end-to-end traceability.

Involved in Troubleshooting of OpenLab HPLC S/W and Agilent 1290 UPLC instrument.

Performing routine QC testing including STAT ELISA, and compendia test methods in support of in-process, release, and stability for Drug Product and Drug Substances.

UHPLC testing of Poloxamer, Triton and Poly-ethylene Imine using Agilent OpenLab S/W

Working knowledge of CE

Knowledge of TCID50, cell culture, genomic assays.

Support of routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)

Sanofi, Framingham, MA

Quality Analyst

Mar 2020-Jun 2021

Gel Electrophoresis of SARS-Cov-2 Proteins Using NuPAGE Pre-Cast Gels (SDS-PAGE)

Western Blot of SARS-Cov-2 Proteins

BCA Total Protein Assay for In-Process SARS-Cov-2 Samples on SpectraMax Plus384 using SoftMax Pro Software, v.7.0.

Review of QC Data for compliance to procedures and specifications.

Participated in training of junior staff.

Transferred methods from support groups to the QC laboratory.

Followed accurate written procedures for testing of in-process and final product samples.

Communicated inter-departmentally and with external contracting units to solve technical issues.

Exercised sound judgment and decision making when problem solving.

Revised standard operating procedures as needed.

AbbVie Bioresearch Center, Worcester, MA-01604

QC Chemist

Aug 2019-Feb 2020

Adept in raw material testing as per USP, EP, and JP compendia.

Worked per the Thermo Fisher Sample Manager LIMS.

Worked on Thermo Fisher-TruScan to verify incoming raw materials and for the inspection of finished products.

Performed monthly water testing per USP compendia.

Familiarity with spectroscopic techniques (FTIR) and particle analysis experience

Carried out Gas testing of- O2, N2, CO2 per USP, EP compendia.

Planned and executed assigned laboratory tasks utilizing standard procedures and technical understanding of various techniques to complete assigned tasks.

Barefeet Analytics, Pune, India

Quality Associate

Feb-2016—Nov 2018

Assisted in testing and calibration, participated in laboratory set up and quality management system that conforms to ISO 17025:2005 and ISO 13485

Evaluating and preparing data reports.

Maintain the inventory of chemicals and materials required for testing and analysis.

Experience in drafting technical reports, quality related documents.

Food Safety- Quality Management

Technical and Scientific Information Support: Participated in specification, purchase and installation of instruments/equipment as well as design of new lab facilities.

Contributed to building Scientific Support Systems and resources.

Roche Molecular Systems, New Jersey, USA

Senior Laboratory Technician

Jan 2013 - Dec 2015

Executed analytical methods for the quantitation of small molecules.

Purified Oligonucleotides using Agilent, Varian HPLC having Waters EMPOWER software.

Handled important case reports in the form of batch record.

Knowledge of GMP, ISO, and FDA regulations and audit

Experience with environmental monitoring, air and water sampling with GMP regulations.

Performed Cross Functional Lab audits for FDA Inspection.

Worked according to the approved validation protocols and reports together in compliance with the quality assurance and making the complete documentation (Batch Record) available for audit and inspection.

Reviewed chromatography data and provided preliminary data.

University of Houston Clear Lake, Houston, Texas, USA

Teaching Assistant/Laboratory Technician

Mar 2012- Dec 2012

Media preparation, Trypsinization and Microphotography of Adherent Cells (HEK-293 Cells)

In vitro and experiments to characterize target enzymes/proteins and antibodies.

Mechanism of interaction of antibodies or small molecules which modulate drug targets.

Cryopreservation of Cells, DNA Transfection of Cells – Calcium Phosphate Method

Maintaining the tissue culture Laboratory and the HEK-293 cell line by routine passages

Genomic Library Construction of λ DNA.

Human DNA Finger Printing- Detection of Alu Insertion Polymorphism by PCR, Detection of VNTR Polymorphism by PCR, used Western Blot and SDS

EDUCATION:

Master of Science in Molecular Biotechnology

oUniversity of Houston, Clear Lake-Houston, TX

Bachelor of Science in Biotechnology

oBharati Vidyapeeth University, India

PUBLICATIONS and PRESENTATIONS:

International Conference Presentation: ASLO Aquatic Science meeting, Feb 17-22, 2013, Stress and Bacterial Involvement in the Production of Prostaglandins by the Octocoral Plexaura

homomalla

Asian Journal of Epidemiology: Antibody Response of children receiving multiple doses of Oral Polio Vaccine in disease free area of India. DOI: 10.3923/aje.2010.75.83

REFERENCES: Can be provided upon request.

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