Jennifer G. Email & Phone Number

Raleigh, NC, US

Billingham, GB

-Technical Transfer and Validation Lead for multiple programs, demonstrating strong organizational and decision-making skills.-As a lead, managed and assigned tasks to team members to ensure efficient workflow and project success-Represented our company and client as a Cell Culture (mAbs) and Downstream SME in multiple pre-approval inspections-Improved.

Billingham, GB

Billingham, GB

Melbourne, Victoria, AU

• Worked with the Technical Development Manufacturing team in a GMP environment
• Bioburden-free BSC work, cell culture, upstream product manufacturing, bioreactors and centrifugation
• Troubleshooting and optimizing a process in development
• Authored technical documents including Summary Reports and SOPs
• Analyzed data for process recommendations in a development setting

• Validation consulting for pharmaceutical clients
• Identified functional requirements and design specifications for software and spreadsheets
• Wrote validation documents including validation plans, design specifications, functional requirements, and IOQs (test cases) for validation testing
• Executed validation protocols

Melbourne, Victoria, AU

• Manufacturing Support:
• Manufacturing and technical support for emulsion based product including creation of statistical tools
• Analyzed process data from batch records and PI historian for yield improvement projects
• Performed root cause analysis on batch yield changes for a process during PPQ
• Created powerpoints intended for training and future use
• Worked with technical documents identifying process change points and decisionsProcess Analytics:

Raleigh, North Carolina, US

I participated in a special program at NC State that focused on global health issues, and how they are affected by epidemiology, and socioeconomic factors.The program focused on the ongoing Ebola outbreak in 2014-2015. During this three week program, we traveled to Ft. Detrick, Maryland to the National Institute of Health to tour the BSL 4 facilities and.

Raleigh, North Carolina, US

In May 2013, I began research in the Medical Implants and Tissue Engineering lab working with Dr. Rohan Shirwaiker. During my time in his lab (May 2013 - November 2014), I made 3-D models for use in tracheal reconstruction research, operated the 3-D bioplotter with biocompatible polymers and other materials, and researched the way that geometry affects 3-D.