Location: Irvine, California
Posted On: 3/14/2017
Job Code: CHEM28CA
Job Description
With limited guidance from supervisor, the employee plans and independently executes analytical chemistry analyses, including but not limited to, HPLC, UPLC, GC, particle size distribution, physical appearance, viscosity, rheometry and drug delivery system release profiles of Phase I / II / III drug products as well as any assigned activities by the supervisor.

Familiarizes with instrumentation and techniques associated with raw material testing and understands compendial requirements to perform difficult compendial test methods. With limited guidance, drafts standard stability protocols/ reports and special study protocols/reports. Works directly with supervisor to maintain the integrity of the stability testing program and LIMS database.

Performs requested data searches utilizing the LIMS database. Under limited supervision, compiles, evaluates and statistically analyzes technical data and generates stability data tables and plots in support of specification development and regulatory submissions. Identifies any atypical data and report to supervisor with probable causes and suggests resolution.

Demonstrates a basic understanding of regulatory requirements associated with stability studies. Evaluates analytical methods and provides feedback and proposes recommendations on method improvements, as required. Troubleshoots instrumentation problems and propose solutions with minimum guidance from supervisor.
Education and Experience:
• M.S. in Analytical Chemistry or related discipline with 0-2 years of experience or B.S. in Analytical Chemistry or related discipline with 3-5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation.
• Minimum 2 years of experience in the analysis of data and writing of technical protocols, reports, and submission ready documents.
Category:IT  code:new
Job Requirements
Analytical Chemistry
utilizing the LIMS database.

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Contact Details
Vishal Singh
E-mail Address