Analyst, Vaccine Franchise / Vaccine Global Supply Planning Department, West Point, PA - December 2009 - July 2010
- Project lead for coordinating 1X Zostavax product launch in Germany to maintain licensure prior to 2X launch. Involved coordinating project timelines, manufacturing, lyophilization, and packaging of product, lab sampling, atypical process reports resolution, batch shipments, and market product licensure requirements.
- Responsible for continued project management through product launch in Europe and Austrailia.
- Served as project lead for implementation of TempTime Vaccine Vial Monitors (individual vial or syringe temperature monitors) on Gardasil product packaged at Harleem, Netherlands facility for European Union markets.
- Served as skid lead for Ultrafiltration (protein diassembly, reassembly, and buffer exchange) step during start-up and process validation demonstration of new HPV Gardasil protein purification facility.
- Authored clean room cleaning procedures and facilitated room qualification/room hygiene performance qualification.
- Provided troubleshooting to Delta V recipes to optimize filtration and purification performance.
- Lead cleaning validation for ultrafiltration skid equipment, including swabbing, rinsate sampling, and TOC analysis.
- Served as shift-lead during Ultrafiltration step of Type 06 Gardasil shakedown lot. Involved directing operators, supervisors, and other engineers on when to take product samples and execute processing steps.
- Utilized Lean Six Sigma tools in Green Belt Project to assign weighment tolerances to biologics raw material weighing and dispensing facility, Project Valuation: $20,000 in labor cost structure efficiency improvements.
- Obtained Six Sigma Green Belt certification.
- Involved generating foru Process Change Requests to assign weighment tolerances for HPV Purification, Buffer, Fermentation, and Alum Adjuvant processes using a rigourous approach involving the interpretation of Merck's significant figure guidelines.
- Addressed and corrected potential cGMP compliance gaps in Primaxin bulk antibiotic sterilization facility.
- Authored atypical, deviation, and environmental monitoring Trackwise investigations to facilitate the release of associated sterile lots.
- Served as project lead for MK-7655 Beta Lactamase (antibiotic resistance) inhibitor filling project for Merck Research Labs' Phase III clinicial trials. Gained experience in clinical trial requirements and methods, multi-product transitioning within a facility, and clean room qualification.
- Successfully conducted a research project that studied the potential impacts that pharmaceuticals in the environment may pose to human health and the environment. My research included modeling the fate, transport, and effects of several high sales volume pharmaceuticals in the environment in an effort to assess any potential risks to Merck's income stream and reputation.
Work Experience at Bio-Tech Pharmacal - Fayetteville, AR - June 2006 - August 2006
- Assisted in the application of cGMP procedures to the manufacture and sale of pharmaceuticals and nutraceuticals
- Facilitated the development of a new company marketing plan and website
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