Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California. We are developing breakthrough therapies for the treatment of acute and intermittent medical conditions. Alexza was founded by Dr. Alejandro Zaffaroni who is one of the most successful entrepreneurs in the biomedical industry with a long list of successful start-ups to his credit, including ALZA, Affymax and Affymetrix Corporations.
We have an exciting temporary opportunity for a Sr. QC Analytical Chemist. This person will work closely with our Quality staff to transition our organization to commercial readiness.
Perform daily QC analytical testing activities to support the product and process development and manufacture of drug/device products
Write, review, and/or implement QC protocols for stability, design verification, test method qualification/ validation, and other quality processes.
Deliver timely, accurate and reliable sample testing results following standard operating procedures in a cGMP laboratory to support product development and release of preclinical and clinical materials. Primary analytical techniques are HPLC, GC, UV, FT-IR, and other wet-chemistry related tests. Conduct and provide guidance to routine analysis and non-routine analysis for raw materials, in process, and finished formulations according to standard operating procedures
Independently works on new assignments and oversees the activities of junior level personnel
Interact at multiple levels and coordinate testing activities cross-functionally
Compile data for documentation of test data and prepare reports
Review QC data for compliance to procedures and specifications and report abnormalities
Refine quality analytical testing methods and compile data for documentation of test procedures
Revise and update standard operating procedures as needed
Train QC personnel on quality procedures.
Perform special project work on analytical and instrument problem solving issues
Apply knowledge of Good Manufacturing Practices and Good Laboratory Practices on a daily basis
May supervise the activities of others, however the primary role is as an individual contributor
Exercises independent judgment to evaluate and solve problems
Must be highly organized, detail oriented and able to manage multiple projects
Ideal candidate will have laboratory skills that include computer controlled HPLC, GC, UV, IR, workstation software, office software (MS Excel, MS Word, etc) and compliance level record keeping
Solid communication and presentation skills required
Supervising experience preferred
Education and Experience:
Requires a Bachelorís Degree, with 8-10 years of experience or Masters degree with 2-4 years of experience in a cGMP quality control laboratory
Experience with USP testing methods a plus
Prior experience in device development or pharmaceutical environment preferred
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