Product Development Technical Support

JUSTIN PARMAR

**, ****** ***, *** # * **, Norwich, NY 13815 Email: **********@*****.**.**

(C) 201-***-****

JOB OBJECTIVE:

To obtain a challenging senior level analytical position utilizing and enhancing experience and knowledge in the field of pharmaceutical product development.

PROFILE:

Total of 12+ years of progressive experience with global pharmaceutical companies specialized in the field of pharmaceutical product development. Recognized for ability to,

Oversee and manage projects to provide analytical support in fast paced environment

Prepare and present accurate documentation to steer strategic team decision-making.

Implement system/procedures with a systematic approach.

SKILLS:

Equipments: HPLC, UPLC, GC, UV, TLC, FT-IR, PSD (Malvern) etc.

Programming: Empower (with Dissolution and MVM option), TotalChrom, LC Solution, ChemStation, QUMAS, ProcessCompliance, istability (LIMS).

Applications: MS Word, MS Excel, MS Power Point.

EDUCATION: Master of Science, Analytical and Inorganic Chemistry, 2003

M. S. University of Baroda, Vadodara, India

WORK EXPERIENCE:

NORWICH PHARMACEUTICALS INC (An Alvogen Company), Norwich, NY

Research Scientist, Method Development & Analytical Services, From February 2010-Present

Oversee and manage projects to provide analytical support for product development and stability for ANDA projects

Prepare laboratory documents including method validation protocols, reports, lab investigation reports, analytical methods, change control etc.

Perform laboratory experiments for method development, method validation, cleaning validation and stability testing

Perform data review for method validation and stability testing in paperless environment using MVM (Empower) and istability (LIMS)

Establish and implement systematic lab improvement projects including Empower (CDS) data acquisition, processing and reporting (paperless), Dissolution option, Method Validation Manager option, Impurity reporting, etc.

Provide technical support for laboratory investigations, HPLC/Empower trouble shooting and training

Create Empower custom calculations, customized reports; work with other departments for more efficient and productive output from Empower

ACTAVIS GROUP (Formerly: Amide Pharmaceuticals), Totowa, NJ

Research scientist-1, Analytical Research Laboratory, From January 2006 – February 2010

Perform method development and validation for drug product dissolution, assay, related compounds, content uniformity, blend uniformity, cleaning verification using HPLC

Prepare analytical method validation protocol and report for drug products

Perform dissolution, assay, content uniformity, blend uniformity, time mixing study, related compounds on finished products for clinical release, product development

Provide technical support for laboratory investigations and general lab equipment trouble shooting

Trained new analysts to perform day to day analysis using HPLC

BIO ARC RESEARCH SOLUTIONS, (Division of Alembic Ltd.) Gujarat, India

Research Associate, Analytical Research, From February– 2005 to December-2005

Manage projects and provide overall laboratory support for product development

Perform method development and validation for drug substance using HPLC

Preparation of validation reports and general laboratory related documents

Perform routine analysis of API and intermediates products using sophisticated instruments like HPLC, GC, Autotitrator, Karl Fischer titrator, FT-IR, UV- visible spectrophotometer etc

CADILA HEALTHCARE LIMITED (USFDA Approved plant), Gujarat, India.

Officer QC/QA, Quality Control Laboratory, From September– 2003 to February-2005

Perform lab sampling of API., Intermediates and row materials from plant.

Perform release testing of pharmaceutical drug substance, intermediates and row materials with sophisticated instruments like HPLC, GC, autotitrator, Karl Fischer titrator, FT-IR, UV- visible spectrophotometer etc

Preparation of COA for raw material, in process and finished drug substances.

Perform cleaning validation studies using UV-Vis and HPLC

Equipment trouble shooting

REFERENCES: Available upon request

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