Expertise

• Quality review of QC stability files and stability protocols for a pre-BLA drug product. Trending and analysis of stability data for annual reports.
• Validation protocols for HPLC, UV-Vis spetrophotometer, particle size analyzer, and atomic absorption instruments.
• Validation master plan writing and implementation
• Connetics, Inc., Palo Alto, CA

Experience

Connetics, Inc., Palo Alto, CA

AeroGen, Inc., Sunnyvale, CA

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).

VALIDATION SPECIALIST

Alza Corporation, Vacaville, CA

• Wrote and executed validation protocols for fluid bed granulators, tablet presses, laser drills, drying ovens, and printers used in the mfg. of extended release tablets.
• Also wrote and executed validation protocols for extruders, form-fill-seal machinery, laminators, mixers, and packaging lines used in the mfg. of transdermal products.
• Wrote and executed cleaning and process validation, including Nitrogen and Helium systems.
• Supervised mfg. of process validation lots for international product transfer.

ANALYTICAL CHEMIST

Alza Corporation, Vacaville, CA

• 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

• American Society for Quality
• International Society of Pharmaceutical Engineers

Education

B.S., Biochemistry, Mathematics, Western Washington University, 1994

CONTINUING EDUCATION:

• Accounting, Econ, & Business Law classes at Solano Community College (96-98)
• ISPE Validation Seminars, SF Bay area (1997-present)
• HVAC Design, UC Santa Cruz extension, Santa Clara, CA (2000)
• Project Management course, UC Berkeley (present)