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Job ID: 4556
Employer: Relypsa
Position: Temporary Analytical Development Scientist
Description: • Develop, qualify and validate analytical methods for release and stability testing
• Evaluate and improve existing analytical techniques and assays
• Conduct routine analysis following SOPs
• Troubleshoot instruments and software issues
• Review/write analytical test methods, protocols and reports; interpret/present analytical data
• Coordinate analytical activities at CRO and CMO (tech transfer, stability coordination, data review)
Requirements: • PhD degree in Analytical Chemistry, or related disciplines with 5+ years in analytical function supporting drug development. BS and MS degree with 10+ years experience will also be considered.
• Hands-on experience in more than one of the following techniques is a must: LC, LC/MS, Ion Analysis Methods, GC, GC/MS, GPC/SEC, solid state IR, NMR, XRD, XPS, DSC, TA and Light Scattering
• Experience with providing rapid turn-around analytical support to process and formulation development (e.g. in-process monitoring, early impurities assessments, excipient compatibility, bio-equivalency studies, etc.) is required
• Ability to exercise independent judgment in developing methods and evaluation criteria for obtaining results is desired
• Excellent working knowledge of the ICH Guidelines regarding Quality and Stability Testing, GMPs and GLPs and other regulatory requirements from IND stage to NDA filing is a plus
• Strong communication and interpersonal skills for a team-oriented environment is required, along with the ability to be flexible and collaborate on projects.
Location: Santa Clara, CA
Contact: apply-sn005@relypsa.com
Post Date: 7/15/2010 11:07:28 AM
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