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Chemist/Associate Scientist
Method Development, Validation, GMP and GLP Compliance
Agricultural Technician
About Me
Industry: |
Science & Biotech |
|---|---|
Occupation: |
Agricultural Technician |
Ideal Companies: |
Genentech, Amgen, Guidance, Gilead Science, Abbott |
Education level: |
Bachelor |
Will Relocate: |
Yes |
Location: |
Sunnyvale, CA |
Work Experiences
3/2003 - 12/2007
ALZA Corporation / Johnson & Johnson
Individual Contributor
- * Developed, optimized, and validated analytical methods for small molecular pharmaceutical compounds, and extended release dosage forms in support of early and late phase formulation.
* Wrote validation protocol, technical report, and analytical method.
* Supported process validation, stability, and method transfer activities to QC/contract labs.
* Compiled data for trend analysis and managed stability results to support clinical batches and marketed products.
* Participated in developing appropriate specifications and acceptance criteria to support product development.
* Conducted peer review for analytical data packages. Trained temporary/regular junior staff.
* Interpreted test results for cross-functional project teams.
* Troubleshot problems in instrument and sample, and performed root cause analysis.
* Collaborated in draft, reviewed and revised SOPs.
* Maintained laboratory cleanliness, and safety in compliance.
* Involved in process improvement processes.
8/2000 - 3/2003
ALZA Corporation
Individual Contributor
- * Developed analytical methods by HPLC, GC, and Karl Fischer for samples at Phase II and Phase III levels. Designed method validation protocol and executed the validation.
* Performed impurity assay, release rate, dissolution, drug content, residual solvent, and water content testing to support OROS formulation and lot clearance.
* Analyzed test results and generated final reports using chromatographic data system.
* Managed equipment calibration/qualifications.
5/1997 - 9/2000
