Description
SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and IR in chemical analysis. * Well-versed in FDA 21 CFR Parts 210, 211 & 820, GMP/GLP/GCP's requirements, quality systems inspections, FDA quality systems/pre-approval inspections, GMP compliance auditing and CAPAs * Conducted experiments using state of the art robotic instruments to support formulations prototypes in a cGMP environment Solid dosage forms formulation utilizing milling, blending, granulation instruments and Tablet press Utilized Agilent HPLC to perform GPC/SEC on some polymer based products Utilized dissolution and HPLC to develop new prototype drugs. * Assumed responsibility of utilizing SPECTROFLAME ICP-OES to analyze blend samples used in manufacturing and also developing method for cleaning validation. * At G&W, he assayed various formulated suppositories and creams for actives and excipients involved in method transfer and validation of formulated pharmaceutical products Pharmaceuticals
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