Management Process

NAVNEET SANDHU

** **** **** *****, ********, NY *2524 413-***-**** **********@*****.***

Objective: Pursue a career as a clinical scientist in pharmaceutical industry.

Education: Bachelors of Science, Chemistry

University of Mass – Dartmouth June 2000

Research Associate Dec. 1999 – Jun 2000

-Synthesis derivatized-porphyrin compounds to be used in photodynamic therapy for the necrosis of adenocarcinoma. Separation of isomers done with gravity column chromatography and various spectroscopic techniques used for the identification of the derivatized compounds.

Skills and Experience:

Laboratory/ Research Skills

1. Experience with “Plant-to-Plate” process in bioanalytical fractionation

2. Separation and fractionation method for Sepiatec 2-D Sepbox 2000 and Teledyne flash chromatography systems equipped with Evaporating Light Scattering Detector (ELSD), in combination with UV detector

3. Beverage analysis and stability studies using Waters Acquity UPLC

4. High Performance Liquid Chromatography (HPLC) analysis of metered-dose inhalant using Waters Alliance, HP Agilent and Shimadzu systems

5. In-process and solvent switching studies using Gas Chromatography

6. HPLC method development and validation, release and stability study for finished drug products, Active Pharmaceutical Ingredients (API) and drug substances

7. Extensive experience working under GMP/GLP regulations and 21CFR Part 11

Technical Experience

1. Experience with CambridgeSoft Electronic Laboratory Notebook (ELN)

2. Developed tracking system for fractionation process using MS-Excel

3. Developed 35 ELN methods using STARLIMS application for a multinational pharmaceutical company

4. Extensive experience with Waters Empower, Agilent Chemstation, PE Totalchrom

5. Equipment installation and operational analysis

6. Calibration and troubleshooting of individual HPLC components

7. Scripting IQ/OQ protocols for SQL-LIMS deployment

8. Harmonization of LIMS protocols for 19 global sites

9. Validation of Perking Elmer (PE) Totalchrom – Chromatographic Data Acqusition System (CDS)

Writing/Documentation Skills

1. Validation and governance documents for change control of SDMS and ELN

2. Basic statistical analysis of analytical data using MS Excel and Sigma Plot

3. Experience in writing and editing HPLC and Karl-fisher standard operating procedures (SOP)

4. Experience in writing and editing chromatographic test procedures for finished drug product, API and raw materials

Communication and Management:

1. Able to manage multiple projects in a given time-frame

2. Positive feedback from working in a team-oriented environment

3. Thrive to provide high-quality work with excellent time-management

4. Experience in providing training and public speaking

Work History:

PepsiCo

Consultant April 2011 – Feb. 2013

1. Fractionation of extracts from global trekking project and creating libraries for long-term research.

LabAnswer

Informatics Consultant March 2010 – October 2010

1. Outlined site-specific deliverables and developed ELN methods in collaboration with scientific and business personnel. Designing methods for interfacing lab equipments and Empower with ELN.

MicroTest Laboratories

Research Scientist March 2006 – August 2008

1. Executed HPLC test procedures for drug products and substances. Raw material testing, using bench chemistry, for major pharmaceutical clients.

Digital Consulting and Software Services

Validation Consultant October 2004 – June 2005

1. Executing protocols for CDS validation and writing scripts for SQL*LIMS deployment under 21CFR Part 11 guidelines.

Boehringer Ingelheim Pharmaceuticals Inc.

Research Associate Feb. 2001 – August 2004

1. Performed stability and release studies for a finished drug product in MDI dosage form. Maintenance of lab equipment and logbooks to be in compliance with GMP/GLP regulations.

Certifications:

Kriger Research Institute (Online)

Clinical Research Associate June 2011

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