Project Manager Years Experience

Julia Epshtein

Fair Lawn,New Jersey,*****

Home: 201-***-****

Cell:201-***-****

E-mail: *************@*****.***

Analytical Project Manager with more than 10 years experience in

Analytical Method Development and Method Validation ( Assay, Related

substances,Dissolution) . My goal is to find a challenging analytical

chemist development position that would allow me to integrate my skills

and experience. I would prefer to utilize my experience with Analytical

methods development and carrying out of their validation.

1 Qualifications summary

. More than 10 years experience in Analytical Method Development and

Method Validation( Assay, Related substances,Dissolution) .

. Wide experience in working with analytical instruments as HPLC-Waters

with Empower software and Agilent with ChemStation software,UV,

PDA,Dissolution -Cary UV Varian

. Planning and caring out of validation. Writing of validation reports

and protocols.

. Extensive knowledge of and experience in drug development and working

in accordance with GLP and GMP requirements.

2 Work Experience

Analytical Project Manager in Analytical Research and Developing

Department 2000-2010 : Dexcel Pharma

Responsibilities include: Methods developing, Performing of analytical

chemistry assay, uniformity of content, gastric resistance, purity and

dissolution based on new and existing methods, operating analytical

instrumentation such as HPLC, UV, Dissolution, Disintegration, Hardness,

Friability, establishing, and validating analytical methods. Performing

of compatibility tests. Management of the stability data protocols.

Writing validation protocols and reports.

3 Education

M. Sc., 1997-2000: The Hebrew University Applied Chemistry department.

Diploma Thesis: "Biodegradable Polymers from PEG and PCL"

Education Experience: GPC, DSC, FTIR, Instron

B. Sc., 1991-1996: Moscow State Academy of Fine Chemical Technology M.V.

Lomonosov.

4 Courses and Certificates

2000: Development of analytical methods by HPLC

2001: Development of validation for analytical methods

5 Languages

English, Russian, Hebrew

6 Article

Biodegradable poly(ethylene oxide)/poly([pic]-caprolactone) multiblock

copolymers

Journal of Biomedical Materials Research

Volume 59, Issue 2, Pages 273 - 281

References will be send upon request.

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