Skilled Leader with proven expertise and success in managing Quality Assurance, Quality Control, and Aseptic Operations. Results-oriented manager working with Biologics, Vaccines, and Oncology products at a site and global level. Possess strong people and analytical skills with ability to work independently and effectively in a team and global setting. I have held several management positions with increasing responsibilities within Microbiology and Quality Assurance. Key capabilities:-Strong Sterility Assurance/Microbiology, Aseptic Operations, Laboratory Operations, Quality, and Compliance background.-Solid aseptic manufacturing and contamination control background.-Experience working with sterile injectable products. I also have experience working with Consumer products in the tablet and liquid form.-Worked on 2 Oncology products through clinical phase to commercial launch. These products were successfully launch in US and EU, as well as several other countries in 2017 and 2018.-Experience with Consent Decree remediation activities.-Extensive knowledge in the following testing areas:Sterility, Bioburden, Endotoxin, Water, Microbial Limits, Cell bank, Microbial Identifications, Growth Promotion, Biological Indicators, Environmental Monitoring, and Stability.-Ability to lead cross functional and global network teams.-Project Management-Drive the implementation/harmonization of Quality Standards, Global Procedures, and best practices across global network.
Listed skills include Aseptic Processing, Gmp, Change Control, Microbiology, and 28 others.