Brian O'Connor
Manufacturing Manager Tech Transfer @ Bristol Myers Squibb
About
SUMMARY Dynamic biopharmaceutical technical leader with deep cGMP experience supporting the development, technology transfer, and commercialization of complex biologics. Proven expertise across CAR-T cell therapy, monoclonal antibodies, and microbial Mfg., with a strong record of leading new product introductions, process validation, and resolution of complex technical challenges in GMP environments. Recognized as a confident, collaborative leader who drives alignment across Mfg., Quality, Engineering, and MSAT. Known for introducing new technologies, improving process robustness, and delivering results in fast-paced, evolving organizations. Passionate about building high-performing teams, bringing clarity, ownership, and momentum to complex technical challenges. TECHNICAL SKILLS GMP MFG, TECHNOLOGY & OPERATIONS EXPERTISE Extensive experience across CAR-T cell therapy manufacturing (selection through cryopreservation) and monoclonal antibody production up to 15 KL scale, including upstream, downstream, and aseptic operations. Led GMP facility reconfiguration and capacity expansion initiatives, ISO 5 aseptic qualifications, airflow visualization, and environmental monitoring program qualification. Oversaw full equipment lifecycle management and implementation of single-use, automation, and digital manufacturing platforms (DeltaV, MES, AI-enabled tools). PROCESS TECHNOLOGY TRANSFER, VALIDATION & MSAT Directed end-to-end GMP process and technology transfer for complex biologics across internal manufacturing sites and external CMOs, delivering facility fit assessments, batch records, SOPs, and manufacturing readiness. Led NPIs across clinical and commercial stages as technical owner and served as MSAT Person-in-the-Plant providing real-time GMP troubleshooting and execution support. Managed validation lifecycles including IQ/OQ/PQ, PPQ, CPV, and process monitoring, with evaluation of PAT and enabling technologies to improve robustness. LEADERSHIP, QUALITY & REGULATORY EXECUTION Provided program-level leadership for cross-functional initiatives spanning Manufacturing, Quality, Engineering, and Facilities. Led complex investigations, deviations, CAPAs, change controls, and risk assessments (FMEA, RCA) while supporting FDA/EMEA inspections, facility readiness, and observation responses. Strong regulatory fluency across 21 CFR 210/211, ICH Q7, and marketing application support.
United States
Bothell
Biotechnology
Operations Management, High Performance Teams, Process Manufacturing, Teacher Mentoring, BA/BE studies, Team Facilitation, Product Lifecycle Management, Equipment Qualification, New Product Rollout, Clinical Manufacturing, Start-up Support, Aseptic Processing, Employee Engagement, Quality Auditing, Rapid Process Improvement, Monoclonal Antibodies, ChatGPT, Quality Risk Management, T cells, Process Validation
Experience
Manufacturing Manager Tech Transfer
Bristol Myers Squibb
Bothell, Washington, United States
Led technical transfer and Mfg. readiness for clinical and commercial CAR-T cell therapy programs, supporting new product introductions including successful NPI of GPRC5D (Arlo-cel) through Phase 2 • Directed complex, cross-functional facility reconfiguration initiatives to optimize space, efficiency, and GMP Mfg. capacity • Led process and facility fit assessments for NPIs, facilitating FMEAs and risk mitigation strategies to ensure success • Equipment: Procurement, induction, installation, qualification, validation, and preventative maintenance • Served as process SME, contributing to the development of batch records, protocols, SOPs, and training program
Sr. Specialist Manufacturing Compliance
Bristol Myers Squibb
Bothell, Washington, United States
Provided Mfg. compliance leadership, driving inspection readiness, quality systems execution, and operational efficiency. • Led facility compliance walkthroughs, authored mitigation plans, and drove closure of identified gaps • Supported FDA and EMA inspections, including facility tours, back-room operations, and responses to regulatory observations • Owned and executed change controls, deviations, and CAPAs within the Quality Management System • Led operational excellence initiatives to reduce deviations and cycle time while maintaining product quality • Supported implementation and adoption of the BMS document management system
Sr. Specialist CAR-T Manufacturing Supervisor
Bristol Myers Squibb
Bothell, Washington, United States
Provided front-line manufacturing leadership for clinical and commercial CAR-T cell therapy production. • Led GMP Mfg. operations: cell separation, activation, induction, expansion, ISO 5 aseptic processing, and cryo • Managed and developed a team of 11 Mfg. associates, driving performance, compliance, and team engagement
Process Lead, Manufacturing
AGC Biologics
Bothell Washington
Provided technical and operational leadership for NPI execution of contract monoclonal antibody products • Supported successful GMP Mfg. of multiple mAb programs through hands-on floor support and technical guidance • Mentored Mfg. staff on bioprocess fundamentals, best practices, and GMP execution • Promoted continuous improvement through Lean and 5S methodologies
Sr. Project Manager, Manufacturing of the Future
Amgen
Seattle Washington
Led strategic manufacturing transformation initiatives supporting global site expansion and modernization. • Supported startup of the Amgen Singapore Mfg. facility, advancing single-use technologies and rapid analytical methods • Designed and delivered manufacturing training programs for 50+ new hires • Facilitated executive governance forums and managed cross-functional teams across multiple global locations
Sr. Project Manager, Operations
Amgen
Seattle Washington
Led global operational programs spanning clinical and commercial product lifecycles • Managed multiple products through development, scale-up, and commercialization decision gates • Developed and deployed global technology transfer business processes to improve product quality, safety, and consistency • Reduced operational risk and repeat deviations through structured knowledge sharing and best-practice implementation • Directly managed four project managers across four manufacturing sites
Sr. Engineer, Global Process Engineering
Amgen
Seattle Washington
Provided MSAT and process engineering leadership for facility startups and global technology transfers. • Supported facility startups and FDA inspections with extensive on-site presence across manufacturing locations • Led process transfer, facility modifications, validation execution, manufacturing runs, and regulatory submissions • Contributed to successful licensure of Amgen Rhode Island and Amgen Fremont manufacturing facilities
Manufacturing Manager
Eden Bioscience
Bothell, Wa
Microbial fermentation, centrifugation, filtration, final formulation, analytics, packaging, transport.
Education
Western Washington University
University of Hawaii at Hilo
Hawaii College of Tropical AG
University of Hawai‘i System
Botany / Marine Biology
Brian O'Connor's Contact Information
Phone
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