Vaughn D Shepherd
Research Scientist II - GMP
Seattle,WA
Summary
Experienced Biopharmaceutical Professional skilled in merging biologic principles with practical manufacturing. Lead in developing downstream operations for lentiviral vector production at Seattle Children's Research Institute, enhancing CAR-T cell therapies. Seeking a Quality Assurance (QA) role to leverage my skills and experience in ensuring product quality and regulatory compliance.
Overview
6
6
years of professional experience
Work History
Research Scientist II - GMP
Seattle Children's Research Institute
Seattle, WA
07.2021 - Current
- Leveraged in-depth knowledge of GMP standards to design and implement robust downstream manufacturing procedures, ensuring high-quality production outcomes.
- Authored, revised, and upheld downstream SOPs and batch records, contributing to a consistent and compliant manufacturing environment.
- Played a key role in process optimization by creating and enforcing CAPAs, significantly reducing deviations and bolstering product integrity.
- Directed cross-functional teams in the onboarding and qualification of complex manufacturing equipment, enhancing operational excellence.
Manufacturing Associate, Purification
AGC Biologics
Bothell, WA
02.2020 - 07.2021
- Ensured adherence to tight schedules by leading shift-change discussions and contributing to pre-process planning efficiency.
- Key contributor during FDA audit, managing SOPs, reviewing GMP documentation, and actively participating in on-floor processes.
- Collaborated on developing improved cleaning protocols with the validation engineering team.
- Proficient trainer in TFF, AKTA process system, and Downstream Core Ops.
Manufacturing Associate, Support
Juno Therapeutics Inc.
Bothell, WA
02.2018 - 06.2019
- Performed batch-processing of media used for upstream and downstream processes in cGMP cleanroom environment of multi-product clinical facility
- Monitored production schedule to keep proper amount of media-stock inventory on hand
- Tested products and subassemblies for functionality or quality and troubleshot problems with equipment, devices or products
- Monitored self and employee actions to ensure adherence to safety procedures
- Inspected finished products for quality and compliance
Education
Bachelor of Science - Biology
University of Washington, Bothell, WA, US
Bothell Sep 2012 - 06.2017
Skills
GMP/GDP - 21 CFR PART 11 Compliance
Corrective and Preventative Actions (CAPA)
Equipment Onboarding & Qualification
Document Management
Root Cause Analysis
Chromatography
Tangential Flow Filtration
Bulk Fill and Filtration
Timeline
Research Scientist II - GMP
Seattle Children's Research Institute
07.2021 - Current
Manufacturing Associate, Purification
AGC Biologics
02.2020 - 07.2021
Manufacturing Associate, Support
Juno Therapeutics Inc.
02.2018 - 06.2019
Bachelor of Science - Biology
University of Washington, Bothell, WA, US
Sep 2012 - 06.2017