Madhavi Nimbalkar

***** ******* **** ***, *******, CA 94536

510-***-****. acv4iw@r.postjobfree.com

MICROBIOLOGIST/ LAB MANAGER/ QC SCIENTIST

Motivated and result oriented Microbiologist/ Pharmaceutical Microbiologist with more than 8 years of experience delivering and designing

innovative solutions along with statistical vigor which meets company objectives. Effective leader and team player, with decision-making and

problem-solving techniques; able to interface with management, clients, and work cross functionally within the organization. Recognized for a

strong sense of pride in handling duties, along with unparalleled commitment to getting the job done and achieving high results. Involvement

with ISO, FDA and GMP related inspections, testing and filings. Multilingual in English, Hindi, Marathi and Sanskrit.

AREAS OF EXPERTISE

Molecular Biology/Pharmaceutical Microbiology Bioinformatics Techniques Leadership and Team Building

Microscopy, HPLC, Data Analysis / QC/ Internal Audit/ filing for FDA, ISO and GMP Technical Documentation & Protocol Design

Assay Validation, Minitab, MS Word, Excel, Project

LABORATORY SKILLS

Microbiology & Pharmaceutical Microbiology Techniques: Efficacy testing Optical microscopy, Western blotting, PCR, ELISA, plaque

assay, conjugation, transfection, transduction, RNA and DNA isolation, cDNA library construction and screening, cDNA synthesis, Plasmid

isolation, Transformation with plasmid, PCR based cloning and sequencing, Microarray analysis.

Protein Biochemistry techniques: Protein isolation, Immunoprecipitation, Gel electrophoresis, Western blotting, whole mount

immunohistochemistry, Immunohistofluorescence (IHF)

Bioinformatics: GenBank searching: BLAST, PSI-BLAST, and PHI-BLAST, Markov models multiple sequence alignments, tree building

using dnamL and PHYLIP, protein sequence analysis tools: wide use of ExPASy web site, Sequence alignment CLUSTALW.

Other techniques: Cell migration, Migration Assay, Boyden chamber assay, BrdU assay, Fura-2 assay, Fluorescence microscopy, Sectioning

mouse organs and Gene knockout.

PROFESSIONAL EXPERIENCE

UNIVERSITY OF NEVADA RENO RENO, NV

(2011 2012)

GRADUATE RESEARCH ASSISTANT

Worked in a cancer biology lab and performed quantitative PCR, cultivated cancer cells, mutation analysis, flow cytometry, Next Gen

sequencing, methylation analysis, mass spectrometry, and molecular imaging.

Worked on a project Role of extracellular S100A4 in increasing ROS production via RAGE in endothelial cells related to

atherosclerosis.

Involved in trouble shooting and implementing in vitro tube assay and Fura- 2 assay.

Presented academic poster on Role of extracellular S100A4 in increasing ROS production via rage in endothelial cells.

Attended American Heart Association conference 2012 held in Los Angeles.

Worked on a Project proposal Role of endothelial S100A4 protein in neovascularization and inflammation in atherosclerosis".

SPECTROCHEM PVT LTD, Mumbai, INDIA

(2007- 2011)

Lab Manager/ Microbiology Consultant / QC Support

Performed Microbial Limit Test (MLT), Quality analysis and Preservative Efficacy test (PET) to analyze HPLC, peptide synthesis

reagents and UV solvents adhering to international standards.

Provided QC support by developing time saving techniques including assay validation as per CGMPs.

Contributed to the development of R & D management office by upgrading SOPs and laboratory techniques.

Recognized as an internal auditor for ISO 9001:2001 and prepared ISO documents for R&D and quality assurance.

Responsible for marketing with technical expertise in GC grade solvents, peptide synthesis reagents, Scintillation and electronic grade

Chemicals, Silane and Boron compounds.

Review, inspect, and approve, audit, filing and assay development as per FDA, cGMP and ISO.

Directed a team by assigning work, instructions and providing with training to build a team efficient in handling Laboratory tools and

equipments.

Conduct Training, document and report SOPs and CAPA investigation.

Collaborate and Regulate quality improvement work with Production Department, Engineering departments for overall quality

improvement.

University Of Cincinnati Cincinnati, OH

(2007-2007)

Volunteer as Research Assistant

Contributed in the study of biochemical pathway of asthma.

Performed western blot assay and created Airway smooth muscle cultures.

Next Services PVT Ltd, MUMBAI, INDIA

(2005-2006)

Senior Healthcare Associate /QA

Conducted in house discussion, training and provided mentoring on revenue cycle management and quality.

Supervised quality of work and analyzed data using statistical methods.

Conducted presentations for clients and educated personnel on US health care system.

PAX CHEM PVT Ltd, MUMBAI, INDIA

(2004-2005)

Senior Microbiologist/Project Manager/ QA support

Performed Microbial Limit Test (MLT) and Preservative efficacy testing (PET) adhering to EU standards. Performed field trials to verify

the quality and its application in cosmetics and baby care products.

Contributed to the development of R& D and Project management office process by upgrading SOPs and other supporting material.

Recognized as an Internal Auditor during the ISO 9001: 2000 Audit and further prepared ISO and cGMP documents for Quality Assurance

Departments and Microbiology Laboratory and supported companies CAPA process

Responsible for Marketing with the technical knowledge in biocides and Preservatives as Project Manager for Lonza Personal Care

Products.

Conducted Product Presentations and Technical Presentations in Johnson & Johnson, Asian Paints and Goodlass Nerolac.

Designed and developed a fully functional Microbiology lab as per the Cities Environmental Health and Safety Department.

Worked on Project related to Assay development and method validation for use of preservatives in exterior and interior paints.

VASU CHEM PVT Ltd, MUMBAI, INDIA

(2004-2004)

Microbiologist and Assistant Management Representative/ QA support - R&D Department

Performed biocide testing and water sample testing to check the efficiency and Quality of biocides used in cooling tower, Boiler and

reverse osmosis.

Conducted Internal audit for ISO 9001:2000 for production, and purchase departments.

Prepared ISO and cGMP documents for Quality Assurance Departments and Microbiology Laboratory.

Liaison with external bodies on matters relating to Quality System.

Provided on-site inspection of cooling towers and performed microbiology test.

Worked on Project related to Assay development and method validation for use of preservatives in baby wash and Lotion.

Professional Development Highlights

EDUCATION

PhD in Cell and Molecular Biology, University of Nevada Reno, NV (completed 29 credit coursework)

2011-2013

Masters in Cancer Cell and Molecular Biology, University of Leicester UK (completed coursework and lab work) 2010

Masters in Microbiology, University of Mumbai, India

2003

Internal Auditor Certification Certified internal auditor from National Center for Quality Management (NCQM)

Technological Skills: Microsoft Word/Excel/PowerPoint/Outlook, SPSS, SYSTAT, R Programming, Minitab, Quality management software.

AWARDS

Promoted as Senior Microbiologist in PAX Chem and Senior Associate in Next Services

Promoted to QC Steering committee in Spectrochem Pvt Ltd

Certified in Regression Models, R programming & Exploratory Data Analysis by Johns Hopkin University on Coursera

KEY SPEAKING ENGAGEMENTS

Poster Presentation for role of extracellular S100A4 in increasing ROS production via rage in endothelial cells

Hosted workshop on microbiological aspects of food analysis at Bhavan's College.

Presenter for Vermi Composting using Leaf Litter, domestic solid waste and enzymes.

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