Scientist Analytical Development

Spectrum Pharmaceuticals, Inc.

Location: Irvine, California-Orange County 92618
Posted on: 9/9/2009 6:25:34 PM
Postion type: Full time
Job Code: Analytical Development
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
Summary:
Conduct analytical development activities for assigned projects to support the development, validation, performance and transfer of analytical methods. Perform samples testing to support stability programs, API and drug product development.

Responsibilities:
* Perform wet chemistry testing according to USP and EP monographs
* Perform laboratory analyses of drug substances, products, in-process control samples and stability samples
* Perform laboratory analyses of solid and liquid formulations
* Conduct analytical method-development, validation, troubleshooting and assist in transfer of HPLC, and other analytical methods typically required for the analysis of drug substances, products, and process control samples
* Write technical reports, protocols and test procedures
* Perform sample analysis to support stability studies, formulation development, and in-process sample testing
* Calibrate, qualify, troubleshoot, and maintain laboratory equipment
* Write SOPs
* Maintain laboratory records, data and logbooks following cGMP requirements
* Perform other duties as assigned by supervisor

REQUIREMENTS:
Skills, Education and Experience:
* Experience in stability testing, method development, validation, qualification, maintenance and use of HPLC and other wet chemistry instrumentations
* Proficient with HPLC method development and validation, specifically using Waters Empower software system, and Alliance hardware.
* Experience in performing sample analyses to determine assay for concentration and potency of drug compounds and perform purity and related substances determination.
* Working knowledge of GLP and cGMP regulations
* Experience in testing drug compounds, formulations, drug substance and in-process samples
* Must work well in a team environment and interact well with other scientists for designing experiments and completing tasks
* Bachelor's, Master's or PhD degree in Chemistry or Pharmaceutical sciences
* A minimum laboratory experience of five years for a BS level candidate, three years for a master level candidate or two years for a PhD level candidate with analysis of drug substances and drug products with a pharmaceutical or biotech company

Availability:
* Occasional evening and weekend work

Travel:
* Occasional travel

EOE. Label