Brian Samuelson
Kenmore
Summary
Senior Bioprocess Development Associate with a solid background in microbial and mRNA manufacturing within cGMP environments. Demonstrated expertise in process scale-up and technology transfer, fostering collaboration between development, manufacturing, and quality teams to enhance product quality and ensure manufacturing readiness.
Overview
10
10
years of professional experience
Work History
Senior Development Associate, Microbial Upstream Process Development
AGC Biologics
Bothell
05.2021 - Current
- Led scale-up and technology transfer of microbial processes from development (5L) to 1500L cGMP manufacturing, supporting process robustness and manufacturing readiness
- Designed and executed DOE-driven studies using JMP to identify critical process parameters and support process characterization efforts
- Collaborated with upstream, downstream, and analytical teams to resolve process deviations, enhancing product quality attributes
- Troubleshot GMP manufacturing issues through data analysis and investigation of process performance, ensuring compliance and operational effectiveness
- Generated and reviewed technical documentation for process transfer activities, facilitating successful manufacturing implementation
- Served as technical lead in client-facing and internal meetings, translating development data into actionable manufacturing strategies
- Established and managed a new process development lab, including equipment selection, setup, and operational readiness
- Supported mammalian (CHO) workflows, contributing to biologics production understanding
Assistant Scientist, R&D – mRNA
Aldevron
Fargo
07.2020 - 04.2021
- Developed and implemented end-to-end mRNA production processes, including IVT, purification, and final fill
- Facilitated GMP tech transfer of mRNA processes to manufacturing in collaboration with MSAT to ensure compliance and efficiency
- Optimized ÄKTA chromatography systems for purification, enhancing process consistency and yield
- Created technical documentation for process transfer and validation, ensuring clarity and regulatory compliance
GMP Upstream Biomanufacturing Operator – Plasmid Production
Aldevron
Fargo
11.2016 - 07.2020
- Executed GMP manufacturing operations for microbial fermentation at 30L and 300L scales
- Maintained batch records, ensuring compliance with cGMP standards to support regulatory requirements
- Supported deviation investigations and implemented CAPA improvements
- Trained new operators, enhancing team capability and operational readiness in manufacturing processes
- Collaborated with PD and Quality teams on continuous improvement
Education
Master of Pharmaceutical Bioengineering -
University of Washington
Seattle, WA06-2024
Bachelor of Science - Biochemistry & Molecular Biology
North Dakota State University
Fargo, ND05-2016
Skills
- Microbial fermentation
- CHO Cell Culture
- Process Scale-Up
- ÄKTA Chromatography
- Process optimization
- cGMP support
- SOP development
- CAPA investigation
- Technology Transfer
- JMP
- Project Management
- Regulatory Compliance
Timeline
Senior Development Associate, Microbial Upstream Process Development
AGC Biologics
05.2021 - Current
Assistant Scientist, R&D – mRNA
Aldevron
07.2020 - 04.2021
GMP Upstream Biomanufacturing Operator – Plasmid Production
Aldevron
11.2016 - 07.2020
Master of Pharmaceutical Bioengineering -
University of Washington
Bachelor of Science - Biochemistry & Molecular Biology
North Dakota State University