Job ID: 4859
Position: Analytical Scientist (SN009)
• Authoring method development reports, validation protocols and reports and related documents to support NDA filing
• Performing virtual QC related tasks (review release and stability data, validation data)
• Development of highly sensitive methods for impurities identification and quantification as well as reference standard characterization (literature search, devising strategies and exploring state-of-the art analytical techniques)
• Evaluation and improvement of existing tests and assays as well as conducting the tests
• Hands-on experience in wide range of state-of-the-art analytical techniques is a must (LC, LC/MS, IC, GC, GC/MS, SEC, IR, NMR, XRD, DSC, TA, Light Scattering) is a must
• Hand-on experience with running Waters, Dionex, and Agilent LC and GC instruments and familiarity with Empower, Masslynx, Chromeleon and Chemstation is preferred
• Excellent working knowledge of the ICH Guidelines regarding GMP quality and stability testing, method validation and related GMP requirements for Phase 3 and beyond is required
• Recent direct experience with writing CMC quality sections for NDA submission is a plus
• Involvement in overseeing and ability to build a highly productive relationship with CMO and CRO is a plus
• Ability to exercise independent judgment in developing methods and evaluation criteria for obtaining results is desired
• Works on complex problems where analysis of situations or data requires an evaluation of intangible variables
• Excellent communication, interpersonal and organizational skills for a team-oriented environment, along with the ability to be flexible and collaborate on projects is required
PhD degree in Analytical Chemistry or BA/BS or MA/MS with appropriate work experience (generally at least 5+ years of work experience in drug development environment).
• Sustained demonstration of technical proficiency, scientific creativity, collaborations with others and independent thought
• Is able to affect results by maneuvering through appropriate formal and informal organization channels – can reach appropriate resolution in many varied situations
• Possesses exceptional ability to analyze and present applicable data
• Demonstrates commitment and enhanced efficiency in quantity and quality of work
• Additional competencies are demonstrated and evaluated, such as: management effectiveness, decision making and adaptability
Location: Redwood City, CA
Post Date: 5/22/2013 10:19:23 PM
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