Quality Control Design

Suresh Patil

Shrewsbury MA *****

Cell: 734-***-**** e-mail ******@*****.***

Well qualified, technically skilled, widely experienced biologist/biotechnologist/molecular biologist is seeking increasingly

responsible positions in the Pharmaceutical/biotechnology industry.

Summary:

Highly experienced in independent management of projects from discovery research through pre-clinical development, product analysis

and testing.

Research Technical Skills:

Cell culture: Aseptic cell cultures DNA Transfections and viral (Lentiviral, retorviral) transduction; Generation of gene silenced strains of

cell lines using siRNA shRNA in primary cultures and cell lines; Transfections, over expression and purifications

In vivo animal work: Small animal survival surgery and experimentation, Tumor Xenograft transplantation analysis; Genotyping

transgenic & knockout mice; in vivo drug analysis (Toxicology, PK/PD/DMPK) & animal imaging; Histology, Confocal Microscopy and

Electron microscopy; Micro manipulation of zebrafish embryo; sperm & oocyte analysis, Bleeding, injections (IP, IV, IM SC) oral gavages)

Molecular Biology: Gene expression and copy number analysis including PCR, RT-PCR, qPCR cloning and sub-cloning, generation of

site directed mutations and sequence analysis expression and copy number analysis, genotyping and SNP analysis

Protein analysis: Experienced in protein isolation, purification and characterization, IEF (Iso electric focusing) urea gels column

chromatography affinity purifications Spectroscopic analysis) Enzyme assays Immuno-histochemistry and immuno-fluorescence,

Immuno-precipitation, SDS-PAGE Western blotting, MSD, ELISA, Design peptides, raise antibodies for native and phospho-peptides (in

house and commercial sources), purify IGG, characterize antibody (monoclonal and polyclonal), titers for end applications

Computer skills: Proficient in computer application including Word, PowerPoint Photoshop Excel and Statistical analysis (T-tests,

ANOVA, ACOVA, Z-tests, parametric and non parametric); On-line literature and DNA/protein data base tools Experienced in Molecular

biology tools, analytical software, LIMS, Documentation and archiving.

Personnel and Project management: Design, conduct analyze and prepare present reports for complex research experiments (in vivo

and in vitro/animal studies) Develop Protocols (SOPs) Interact with clients/ outside organizations Screen recruit train and supervise

personnel.

Education:

M.Sc. Biological sciences (Reproductive endocrinology)

B.Sc. Chemistry (Major) Biology

Professional experience:

Senior Research Associate: Toxikon, Bedford MA 04/2012-

• Develop, optimize and perform various cell based assays

• Perform transformation of DNA into bacteria, transfection into mammalian/bacterial cells, harvesting the protein for purification using

chromatography and quality analysis using SDS-PAGE ELISA spectroscopy

• Develop Immuno-staining based protein expression analysis on cultured cell line for identification of biomarkers for the testing

compounds

• Record and analyze the experimental data and report the findings in a timely fashion

• Conduct Toxicology, TK/PK/PD/DMPK analytical studies for test compounds in animal models (Mice, Rats, Rabbits, Dogs), analyze

blood, urine, related biological samples, process tissue for histology.

• Write review regulatory documents, IUCUC protocols, evaluate quality compliance,resolve conflicts

• Organize and maintain experimental records

• Maintain cell cultures transformation of DNA into bacteria, transfection into mammalian cells

• Testing the effects of compounds in cell based assays like Proliferation Assays, Viability Assays and Apoptotic Assays etc in Oncology

research

• Conduct animal experiments (Rats, mice, canines, rabbits) for toxicology, efficacy, PK/PD/DMPK analysis of the drug, collect blood

and tissue samples, process, assay, and generate reports as required.

• Assist in tissue processing for histology, histochemical staining, and immunohistochemistry

• Support discovery and characterization of therapeutic anti-bodies for the treatment of various diseases, using protein purification

techniques

• Receive, distribute material, perform quality analysis on substances/material and evaluate results, verify FDA/USDA compliance

documents write edit update SOPs, train retrain personnel after SOP modifications

• Maintain compliance under GLP (21CFR part 58) develop assay methods to be manufactured under 21 CFR 210/211 and ISO

standards, maintain quality control checks and establish electronic records.

Research Associate: Target validation, Oncology division, Sanofi-Aventis Cambridge MA 05/2011-02/2012

• Develop gene silenced cell lines using siRNA shRNA / lentiviral transfections, expressions and analysis (BSL2+)

• Examining the effects of a gene siRNA knockdown in cancer cells on a particular signaling pathway by Reporter Assay

• Characterization of drug resistant cancer cells in respect to cell viability, proliferation, morphology

• Design, develop cell based assays, ELISA, Apoptosis FACS (scan and sorting) Establish IC50 of test compounds

• Maintain mammalian aseptic cell cultures; establish 2D, 3D cell cultures, SDS-PAGE, western blots

• Isolate DNA RNA, perform PCR qRT-PCR Taqman expression and copy number assay, gene fusion cloning and sequencing

• Support general laboratory maintenance, equipment calibrations and safety

•

Research specialist, Gene therapy center Univ. Mass Medical School Worcester MA 06/2010-05/2011

Research specialist, Dept. Ophthalmology, Univ. Michigan, Ann Arbor MI (Moved to UMASS see above) 02/2009-05/2010

• Assist in identification of mechanism of neuro degeneration in retina, kidney brain related neuronal tissue

• Isolation of RNA, RT-PCR, cDNA synthesis, cloning isolation of plasmids, Design primers cDNA mutations and manipulations, vector

constructions, transfections

• Production of shRNA mediated knock down of gene expression and development of cell lines and based assays

• Identify SNP genetic mutations in human and mouse develop PCR assays validate results

• Development of Immunocytochemistry (immunohistochemistry) methods for various antibodies

• Perform paraffin microtomy, cryo-sections and plastic sections for and Histology immuno-Histochemistry

• Transmission electron microscopy, plastic embedding and semi thin sectioning, image analysis and documentation (TEM)

• Identify SNP genetic mutations in human and mouse develop and optimize FISH (fluorescent in situ hybridization)

• Confocal Microscopy and Electron microscopy Histology immuno-Histochemistry

Research Associate, Dept. of Pediatrics & radiation oncology, Univ. Michigan, Ann Arbor MI 04-2003-02/2009

• Examine c-myc oncogene-induced senescence, inhibition of gene expression, transfections and Lentiviral transduction;

• Develop and maintain melanoma cell lines

• Generation of gene silenced strains of cell lines using siRNA shRNA in primary cultures and cell lines;

• Pharmacological studies, cell based assays

• Develop chemiluminiscent assay methods ELISA RIA for EGFR /ERB2 phosphorylation and downstream signaling.

• Examine effects of gefatinib and lapatinib on EGFR phosphorylation

• Small animal handling surgery and experimentation, Tumor Xenograft transplantation drug and pharmacological analysis

• Run rodent models of cancers and conduct PK/PD and efficacy experiments to examine inhibitory effects of compounds

• Perform live animal imaging using Xenogen (luciferase chemiluniscence)

• Perform biochemical and/or histological analysis of tissue samples

• Perform data analysis, interpretation of results and written documents for publications

Research Assistant, Dept of Pediatrics, GI Division Univ. Michigan, Ann Arbor MI USA 04/2001-03/2003

• Isolate smooth muscle from GI track from Human Rabbit and mice,

• Develop stable cell lines from primary cultures

• Examine signal transduction in smooth muscles

• Protein purifications, protein n analysis Immuno-precipitation, SDS-PAGE Western blotting,

• Isolation of RNA, RT-PCR, cDNA synthesis, cloning isolation of plasmids Design primers cDNA mutations and manipulations, vector

construction, transfections

Accomplishments:

• Authorship in several high impact journals including first author

• Independently Design and conduct in vivo and in vitro experiments analyze and generate reports as required

• Developed chemiluminiscent assay methods for EGFR /ERB2 phosphorylation and downstream signaling using firefly

luciferase

• Developed and standardized immune histochemistry protocols for many proteins for fluorescent and confocal

microscopy

• Developed and standardized immunogold protocol for electron microscopy

• Develop and document SOP

• Small animal experimentation, survival surgeries, dose standardizations and compound evaluations (IP, IV,SC, IM, Oral

gavage),

• In vivo TK/PK/PD studies( toxicology and efficacy assessments) using rodent /rabbit/canine models design analyze modify

experimental protocols according to clients needs

• Experienced in all aspects of wet molecular biology research worked under GLP and GMP environments in compliance with

FDA/NIH/USDA/ICH

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