Regulatory Affairs

Vanessa Coulibaly

*** ***** ****** ********, ** *8840

Phone: 908-***-**** E-Mail: ********@*****.***

Objective

Multilingual

advanced

degree

scientist

looking

to

gain

further

experience,

with

the

opportunity

to

combine

analytical

and

management

skills

with

the

drug

development

process.

Education

Masters

of

Business

and

Science,

September

2013

–

May

2105

Drug

Discovery

and

Development

Rutgers

University,

New

Brunswick

NJ

Bachelor

of

Science,

September

2004-

May

2008

Biochemistry

and

Molecular

Biology

Penn

State

University,

University

Park,

PA

Experience

Research

Assistant

July

2014

–

Present

Dr.

Linda

Brzustowicz

Laboratory,

Chair

of

Genetics

Department,

Rutgers

University

Studied

the

relationship

between

schizophrenia

and

22q11.2

deletion

syndrome

in

human

samples

and

cellular

models.

• Induced

human

fibroblasts

into

pluripotent

stem

cells

and

later

into

neural

stem

cells

for

DNA/RNA

extraction

and

cell

characterization.

• Trained

upcoming

Ph.

D

students

to

enable

them

to

function

autonomously

within

the

lab.

Senior

Lab

Technician

February

2010

–

Present

RUCDR

Infinite

Biologics

• Developed

work

instruction,

SOP,

and

preventative

maintenance

documentation

and

provided

reports,

data,

and

information

to

support

on-

going

operations

based

on

regulations

and

project

requirements.

• Provided

summary

reports

and

weekly

projects

updates

to

support

senior

management

decision-

making

process

and

interactions

with

clients

with

the

assistance

of

laboratory

software

(LIMS).

• Validated

novel

processes

and

protocols

to

obtain

new

contracts

with

new

and

long-

standing

clients.

• Provided

equipment

and

facility

support

such

as

managed

inventory,

generated

work

orders,

and

coordinate

repairs

&

modifications.

• Extracted

and

purified

DNA

from

blood,

saliva,

and

cultured

cells

in

a

high

throughput

automated

biosafety

level

2

laboratory

to

further

the

research

of

autism,

organ

diseases,

drug/alcohol

abuse,

and

many

more.

Visual

Manager

January

2009-

August

2009

Abercrombie

and

Fitch

• Trained

and

motivated

store

team

of

25

employees

to

provide

superior

customer

service

and

consistent

execution

of

all

operational

functions

to

company

standards.

• Directed

and

executed

strategic,

brand

appropriate

merchandising

to

maximize

sales

and

presentation

standards

as

per

directives

from

corporate.

• Consistently

met

or

exceeded

corporate

daily

sales

goal

of

an

average

$10,000.

Industry

Knowledge

• Understanding

of

all

the

phases

of

drug

development

and

related

regulatory

dossiers.

• Thorough

understanding

of

FDA

regulations/ICH

guidelines,

budget

terms

and

concepts,

and

scientific

terminology

and

testing

procedure

requirements.

Contact this candidate