Job Title: Scientist 3
Duration: 6+ months with possible extension
| The position will involve multiple projects, primarily the test method validations of two Waters' 1525 analytical HPLCs and secondarily the performance validation of a Waters' 2545 preparative HPLC for small organic compounds and peptides. Validations involve the candidate's hands-on operation of sample preparation, manual sample injection, and generation of chromatographic reports for characterization and qualification of FDA-regulated production materials destined for in-vitro diagnostic products. Daily activities would include sample preparation and performing HPLC analyses on test materials, data analysis, writing of process descriptions and data into formalized pre-set document templates such as technical studies and report, along with validation protocols and reports.
Familiarity with the aforementioned HPLC models and Waters' Empower 3 software or similar models and software is required. Proficiency in technical writing is also required, as is experience working in a GLP and GMP laboratory. Although not necessary for this position knowledge of organic synthetic routes and purification schemes would be advantageous. Similarly, experience with other analytical methods such as mass spectrometry, NMR, and UV-visible/IR spectrophotometry would also be useful. The work environment will involve collaboration with organic chemists within the group, and interaction with quality assurance and validation personnel in separate departments. At all times the candidate must be able to work safely and independently in a team environment, and manage several projects simultaneously and efficiently.
Education: Bachelor’s degree in chemistry with 5+ years experience, or Master’s/PhD degree in analytical chemistry with 0-2+ years, of relevant experience in HPLC analysis and validation. Industrial experience is preferred |
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Thanks and Regards,
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560