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SCIENTIST II, ANALYTICAL DEVELOPMENT-130569
* 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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