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| Title of job: |
Analytical Development Scientist |
| Job Location: |
Menlo Park, California, 94025 |
| Job Type: |
Contract to Hire
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| Price Range: |
| Negotiable, Depending on experience |
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Business |
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Professional |
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Scientist |
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| Qualifications: |
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| Job/Project Details: |
This analytical development scientist Position Features: In addition, this temp needs to be versatile to cover for data review, actual hands-on work, elution, temps, bioassay, and soln prep. Job Description Purpose of Job: Support R&D and Operations by developing and validating analytical methods and transferring those analytical methods to QC. Provide testing as needed for special studies. Major Duties and Primary Responsibilities: Develop and optimize analytical methods for testing of raw materials and drug-eluting stents (hands-on laboratory work). Conduct validations appropriate to the stage of the project to support early R&D efforts through commercial product release. Contribute to the continuous improvement of analytical methods Work with Analytical QC in preparing for and conducting transfer of methods. Write method development histories and document continuous improvement of analytical methods. Write protocols and test reports Work in compliance (including documentation) with all US (e.g., FDA Guidelines, USP, GLP, and cGMP) and international regulatory agencies (e.g. ICH Guidelines, EMEA Guidelines) and compliance requirements (GLP, cGMP and Quality System) as they relate to analytical testing and laboratory operations. Job Requirements: Doctoral or Masters Degree in Chemistry with a minimum of 4 years experience in pharmaceutical development or drug delivery with a focus on analytical chemistry, or equivalent combination of education and experience. Ability to lead a portion of a project and be wholly responsible for that portion. Familiar with ICH Guidelines, USP, GLPs and cGMPs. Experience with HPLC and other relevant analytical techniques. Advanced computer skills specifically in Microsoft Word, Excel and analytical chemistry software such as chromatography data systems and LIMS. Excellent written and verbal communication/presentation skills. Experience with DOE a plus. df-jb |
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