- Pharmaceutical and medical device process and equipment validation.
- Pharmaceutical quality control, quality review of pre-BLA (Biologic License Application) drug product, and stability analysis.
- Validation of HPLC, UV-Vis spectrophotometer, particle size analyzer, and atomic absorption instruments.
- Created and wrote IQ/OQ validation protocols for sterile washers, dry heat ovens, and robotic filling and capping equipment used in aseptic manufacturing of implantable controlled release systems.
- Executed validation protocols for fluid bed granulators, tablet presses, laser drills, drying ovens, and printers for extended release tablets.
- Wrote validation protocols for extruders, form-fill-seal machinery, laminators, mixers, and packaging lines for the manufacture of transdermal products.
Independent Consultant, Validation Engineering, 1998 - Present
- Quality review of quality control stability files and stability protocols for a pre-drug product.
- Trending and analysis of stability data for annual reports.
AeroGen, Inc., Sunnyvale, CA
- Validation protocols for HPLC, UV-Vis spetrophotometer, particle size analyzer, and atomic absorption instruments.
- Validation master plan writing and implementation.
Alza/Sequus Pharmaceuticals, Menlo Park & Palo Alto, CA
- Wrote and executed PQ protocols Alza's Finn Aqua autoclave.
- Work included process development for diverse load configurations, knowledge of BI use and handling, and the operation of Kaye Digistrip data collectors.
- Wrote and executed IQ/OQ validation protocols for sterile washers, dry heat ovens, and robotic filling and capping equipment used in aseptic manufacturing of implantable controlled release system in a Class 1000 facility.
Proctor & Gamble Pharmaceuticals, Norwich, NY
- Wrote and executed packaging and bottling line validation protocols.
Cohesion Technologies, Palo Alto, CA
- Wrote and executed validation protocols for analytical equipment (Densitometer and UV-Vis).
Alza Corporation, Vacaville, CA, 1994 - 1998
- Wrote and executed validation protocols for fluid bed granulators, tablet presses, laser drills, drying ovens, and printers used in the manufacturing of extended release tablets.
- Authored and executed validation protocols for extruders, form-fill-seal machinery, laminators, mixers, and packaging lines used in the manufacturing of transdermal products.
- Wrote and executed cleaning and process validation, including nitrogen and helium systems.
- Supervised manufacturing of process validation lots for international product transfer.
Analytical Chemist, 1994 - 1995
- Proficient in the use of liquid and gas chromatography analytical equipment (HPLC and GC).
- Performed batch release assays for transdermal and oral tablet products.
Honors & Publications
- Accounting, Economics and Business Law classes at Solano Community College
- ISPE Validation Seminars, San Francisco
- HVAC Design, UC Santa Cruz extension, Santa Clara, CA
- Project Management course, UC Berkeley
Academic and Professional Affiliations
- American Society for Quality
- International Society of Pharmaceutical Engineers
- B.S. Biochemistry, Mathematics, Western Washington University