Jennifer G. Email & Phone Number

Raleigh, Nc, Us

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 onboarding practices and materials while on Process Development Training Committee-Special project on Program Profitability reporting directly to VP of Process Development (1 year)-Managerial experience with three direct reports leading the Process Sciences Intern Program (2022/2023)-Authoring Validation Master Plans, Validation Protocols, Criticality Assessment Reports, Summary Reports and other technical documents for multiple Process Performance Qualification campaigns-Writing Unicorn Methods and DCS Recipes for processing equipment-Executing validation protocols, technical studies, and water runs for multiple programs-User Requirement Specifications (URS) and Factory Acceptance Test (FAT) for new equipment-Root Cause Analysis, Technical Impact Assessment and Ownership of Deviations-Leading Corrective Actions and Change Controls for multiple validated programs-Evaluation of raw materials and process equipment for new product introduction (NPI) in a GMP facility-Designing custom consumables to streamline processing-Reviewing process-related BLA and IND submission sections

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:• Collected and analyzed manufacturing data for process monitoring and improvement• Authored weekly updates on all critical process parameters• Presented relevant data to site leadership monthly for product life cycle management • Generated Control Strategy Assessments of multiple pharmaceutical processes for the implementation of different stages of Continued Process Verification.• Wrote and revised Minitab macros that were used for Statistical Process Control.• Worked with PI Processbook to monitor real-time manufacturing data.• Collected and verified process data from official batch records, LIMs and OSI PI for CPV trending and reporting.• Helped generate the yearly CPV report for the cell culture derive flu vaccine

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 speak to leading researchers on the Ebola outbreak. Following the trip to Maryland, we had the opportunity to meet with Dr. Larry Kerr on the White House National Security Council to speak about the US response to the Ebola outbreak. We also spoke to members of Homeland Security and the US Agency for International Development. The goal of the program was to understand the global response to the epidemic, how our government responds to global health crises here and abroad, and the socioeconomic factors that led to Ebola epidemic.

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 printed structures. In Fall 2013, I was awarded the Abrams Undergraduate Research Scholarship for an individual research project under Dr. Shirwaiker's mentorship.I switched labs in November 2014 to begin working with Dr. Walker in the Tiny Biotools lab at state. During my time there, I investigated flow rates through microfluidic tubing, and explored contamination in the tubing using a model with food coloring and different flow rates. I left this lab in May 2015 after accepting an offer to intern at Seqirus (formerly Novartis Vaccines).