Manager Project

Nirav Desai

** **. ********* ****** #**** ? BOSTON, MA 02120

************@*****.*** ? 857-***-****

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~ Summary of Qualifications ~

. Dedicated team member and collaborator with the ability to partner with

multidisciplinary teams and colleagues through all phases of scientific

research and manufacturing projects.

. Proven success designing, coordinating and executing studies that explore

new concepts and ideas in molecular biology, bioanalytical assays and

process development.

. Excellent capacity to make keen observations and accurately track,

analyze and report quantifiable data in cGMP and GLP environment to

ensure the projects produced verifiable, repeatable findings.

. Outstanding communication, interpretation and presentation skills.

Education

Master of Science (MS) in Biotechnology, 6/2012

NORTHEASTERN UNIVERSITY, Boston, MA

Bachelor of Science (BS) in Pharmacy, 4/2010

NIRMA UNIVERSITY, Ahmedabad, Gujarat, India

Laboratory and Technical Skills

TECHNIQUES INSTRUMENTS SOFTWARE TOOLS

qPCR/RT-PCR/Gene Cloning BioRad T100 Thermal Cycler Microsoft Suite

Gel Electrophoresis ForteBio Octet QK DNA Star

Protein Expression Vi-CELL XR AlphaInnotech

/Purification

SDS-PAGE/ Western Blot GE Typhoon 9400 VectorNTI

Assay Development Agilent HPLC 1100 LIMS

FPLC/HPLC AKTA FPLC BLAST

Southern/Northern Blot Qiagen Universal Biorobot Primer Express

8000

Aseptic technique/Cell Perkin-Elmer Scintillation Peak Scanner

Culture Analyzer Sequencher

Biorobot Operations Qiacube Empower

Genotypic Profiing 7500 RT PCR System

Professional Experience

PFIZER, Andover, MA

Associate Scientist (09/2012 to present)

As an integral part of Cell Line Development Group; oversaw mammalian cell

line maintenance, cryopreservation and stable cell line generation.

Performed RNA, cDNA, plasmid and genomic DNA preparation on routine basis.

Designed experiments to optimize the reaction and storage conditions to

maximize genomic DNA yields.

Analyzed multiple sequence alignments to identify sequence variants using

ECS assay. Assisted the group with multiple genotypic profiling projects.

Utilized automated platform for high throughput screening of the sequence

variants.

Key Contributions:

. Designed and conducted mammalian cell culture experiments covering

cell counting, seeding, cryopreservation and cell banking. Outlined a

series of experiments from a scratch to characterize host cell bank to

get optimum gDNA yield.

~ Mammalian Cell Culture ~

RNA/cDNA/gDNA Preparation

. Executed qPCR and Octet operations in 96 well format to figure out

consistency of the cell lines in terms of gene copy number and titer

over extended generations.

~ Gene Copy Number Count ~ Antibody

Titer Measurement

. Performed genotypic packages for biological drug candidates to study

the integrity of the transcript and stability of the cell line,

documented all lab activities in e-notebooks as required, in a timely

manner.

~ Northern Blot ~

Southern Blot

NEW ENGLAND BIOLABS, Ipswich, MA

Research Associate (1/2012 to 8/2012)

Collaborated with team members in executing all phases of research for a

first-of-its-kind biotechnology project titled "Reconstitution of Archaeal

Replisome Assembly." Monitored, tracked and reported on processes and

findings. Conducted presentations for large groups with up to 150

attendees.

Key Contributions:

. Cloned 9N archaeal replisome genes into plasmid using Gibson cloning

method, and effectively transformed plasmid to cloning and expression

strains of E.coli to produce 9N archaeal proteins.

~ PCR ~ Gene Cloning/Expression

~ DNA Isolation

~ SDS-PAGE ~ Protein Characterization

~ DNA Sequence Analysis

. Successfully cloned and expressed 9N Polymerase D, paper on

identification and biochemical characterization of 9N PolymeraseD is to

be published in a reputed Journal.

~ Protein Expression/Purification ~ Bioanalytical

Assay Development

. Utilized AKTA FPLC to purify proteins, and successfully

developed/modified bioanalytical assays to demonstrate and characterize

protein activity and interactions.

~ Ion-Exchange Chromatography ~ Size-Exclusion

Chromatography

~ Minicircle Assays ~

Processivity Assays

. Visualized DNA replication using 9N archaeal minimal replisome at the

using Zeiss Apotome microscope; results of the work are intended for

publication in respected industry journal.

~ Digital Imaging ~ Enzyme

Kinetics

DEPARTMENT OF BIOLOGY, NORTHEASTERN UNIVERSITY, Boston, MA

Research Assistant (12/2010 to 12/2011)

Provided support and assistance in project to study persister genes in

E.coli. Constructed plasmids and transformed into E.coli, oversaw cloning

and sequencing (PCR) and evaluated the reactions between persister gene

proteins and hipA, EF-Tu and possible suppressor proteins (GST pull-down

assay).

Key Contributions:

. Successfully applied theoretical concepts and literature searches into

complex scientific research.

. Worked diligently to expand knowledge and achieve short- and long-term

project goals.

~ Gene Cloning ~ PCR

~ GST Pull-Down Assay

~ Transformation ~ SDS-PAGE

~ Plasmid Construction

NORTHEASTERN UNIVERSITY, PHARMACEUTICAL SCIENCES LAB, Boston, MA

Graduate Research Student (8/2011 to 12/2011)

Utilized molecular biology techniques in course work lab for design,

development and execution serving investigation into mouse embryonic

fibroblast cells(NIH 3T3) cloning, expression, and analysis.

. Gained hands-on experience on basic molecular and analytical

techniques.

~ ELISA ~ Western Blot

~ HPLC

RELISH PHARMACEUTICALS LTD., Ahmedabad, Gujarat, India

Assistant Manager (7/2008 to 6/2009)

Supervised batch production of tablet dosage forms for flawless quality and

consistency in cGMP regulated environment. Validated the pharmaceutical

master formulary. Collaborated with several departments for in-depth

analysis and trouble shooting. Maintained batch manufacturing

records/results.

Key Contributions:

. Optimized batch production for speed, efficiency and accountability.

. Trained the machine operators and supervised operations

. Performed calibration, preventive maintenance and trouble-shooting on

Analytical Instruments under cGMP regulated environment, maintained and

revised SOPs.

~ CAPA

~ Root Cause Analysis

FOOD AND DRUG CONTROL ADMINISTRATION, Gujarat, India

Student Intern (12/2008 to 2/2009)

Collected drug samples from different pharmacies to evaluate the potency

and reported at FDCA.

** *** **

Also served as Video Director (Video Directing Office)

and Proctor (Resident Security Office) for Northeastern University.

Community Involvement

Volunteer, Swasthya Sewa Trust NGO - Traveled to different villages in

India to promote awareness of AIDS, cancer and other diseases.

~ References available upon request ~

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