Description
SUMMARY Consistent, hard working, and highly motivated individual who has over 10 years of experience working in an FDA and SFDA regulated environment within an organization that follows current good manufacturing procedures (cGMPs). Reputation built on excellent support and follow through with attention to detail and commitment. Extensive experience and knowledge with analytical instrumentation such as HPLC (UV/VIS, PDA, RID, ELSD), GC, dissolution, KF, FT-IR, MS and wet chemistry procedures. Great working knowledge on various computer software such as Shimadzu Class VP, LC Solution, Waters Empower and Agilent Chemstation. Strong analytical aptitude and ability to comprehend and apply scientific theory and analytical techniques to solve problems. Extensive experience on developing, establishing, and validating stability indicating methods for Immediate Release Solid Dosage, Extend Release Solid Dosage, Oral Dosage, Patch, Suspension, and Inhalation. Proficiency in technical writing for release specification for drug substance and finished product, method validation/verification protocol and report.
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