Kelly Gray
Simi Valley,CA
Summary
Hard working and ambitious Process Development Engineer with a strong desire to learn and lead, as an individual contributor and in group settings. Experience in improving and managing workplace operations. Excited to contribute technical skills and a strong work ethic to a focused team.
Overview
5
5
years of professional experience
Work History
Process Development Engineer
A2 Biotherapeutics
Agoura Hills`, CA
07.2024 - Current
Associate Process Development Engineer II
A2 Biotherapeutics
Agoura Hills, CA
05.2022 - 06.2024
- Co-Project Managed integration and execution of Final Process Stability project, including visual inspection, cell recovery, strength, and potency assays, as well as GDP documentation, scheduling, and close-out
- Led implementation of new analytical capabilities and IND-enabling studies into team, including optimizing assays, developing training processes, executing training, and managing scheduling and logistics for company-wide benefit
- Support IND authoring for flow cytometry panels and ddPCR assays
- Designed and executed ddPCR and flow cytometry bridging studies between instruments to support Quality Control
- Led implementation of Complete Blood Count (CBC) instrument use and maintenance into team to compile and characterize healthy donor and patient apheresis
- Characterized cell culture medium stability and conditioned media metabolite consumption and production for three programs
- Led and organized effort for maintenance of team's required analytical materials
Bioprocess R&D Associate
PBS Biotech Inc.
Camarillo, CA
01.2020 - 05.2022
- Managed client project characterizing and optimizing scaled-up process for MSC cell line, including co-authoring two technical reports outlining research processes and procedures
- Designed and optimized novel and unique procedures for the scaled-up seeding, growth, counting, and harvesting of iPSCs using vertical wheel bioreactors
- Successfully oversaw and reformed Materials Management of lab, including improving inventory maintenance, purchasing, and training procedures
- Authored dozens of technology-transferred Standard Operating Procedures
Education
Master of Science - Biotechnology
University of Maryland Global Campus
Adelphi, Maryland03-2025
Bachelor of Science - Chemical Engineering
University of California
Irvine06.2019
Skills
- Project Management (PMP Certified)
- Communication/Presentation
- Data analysis
- Large and small-scale cell culture
- Technical writing
- Process Design & Characterization
- Flow Cytometry
- ddPCR
- ELLA
- Potency
- Stability testing
- GDP
- Teamwork
Timeline
Process Development Engineer
A2 Biotherapeutics
07.2024 - Current
Associate Process Development Engineer II
A2 Biotherapeutics
05.2022 - 06.2024
Bioprocess R&D Associate
PBS Biotech Inc.
01.2020 - 05.2022
Master of Science - Biotechnology
University of Maryland Global Campus
Bachelor of Science - Chemical Engineering
University of California
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