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Date: 12-Feb-2013
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* Performs the assigned analytical tasks with minimum supervision in support of product development, registration lot release, pre and post regulatory submission activities. * Supports analytical method development, validation and project support. Identifies technical challenges during analytical method development and perform method trouble shooting. These activities will be performed under supervision. * Proactively participates in activities in support of process changes (e.g. processes, procedures, etc...). Mentors peers on instrumentation and analytical methods. * Follows work instructions, SOPs, company practices and regulatory guidances/regulations. Documents analytical activities and results accurately, in a timely manner and right-first time. Reviews and checks analytical data generated by peers and maintains integrity of data. * Communicates effectively with peers, supervisor, management and internal customers about the status of the assigned activities, , maintaining supervisor constantly updated.

* If experience is in c-GXP analytical laboratories: Bachelors degree and MS in a scientific discipline such as Chemistry, Pharmaceutics or Biology with a minimum of 3 years of experience, or BS/BA in a scientific discipline with a minimum of 4 years of experience. * If experience is in non c-GXP analytical laboratories additional 2 years are required. * The work related experiences include physical and chemical testing activities of organic materials. Prior experience in a c-GXP regulated environment and pharmaceutical industry is preferred. * Experience in HPLC is required. Experience in one of the following GC, particle size, dissolution, droplet size, AA, and DSC/TGA is preferred * Practical Knowledge of the critical functions/variables of the analytical techniques listed is also required. * Experience with data acquisition software is desirable. * Knowledge of the most current FDA/ICH guidance’s and national Pharmacopoeias is preferred. * Must be able to work in a team environment approach to accomplish tasks assigned. * Must possess the ability to work on multiple tasks in a fast pace environment. * Must possess good written and verbal communication skills. * The candidate must have the ability to work under supervision using scientific judgment and professional competency.

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BioTech FYI Center