Bristol Myers Squibb
Senior Manager, Process Monitoring Systems Lead
Bristol Myers Squibb, Seattle, Washington, us, 98127
Senior Manager, Process Monitoring Systems Lead
Working with Us: Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. The Process Monitoring Systems Lead will be responsible for the establishment and maintenance of systems to support process data trending programs for the commercial and late-stage clinical vector products across the cell therapy network. This individual will be responsible for statistical process control program and continued process verification for the network. Key Responsibilities:
Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs. Serve as the interface for CMO sites, product teams and laboratories ensuring consistent data monitoring activities. In partnership with product and site teams execute end to end product robustness reviews. Promote innovative and efficient approaches to SPC and CPV based on risk-based elements and considerations unique to cell therapy production. Manage complex cross-functional projects/programs using project management techniques and tools. Partner with IT, MS&T, and AS&T to create and maintain required data structures or hierarchies. Train end users on process robustness systems and procedures. Qualifications & Experience:
Bachelor's degree or equivalent in relevant discipline with a minimum of 8-10 years of relevant experience. Expertise in statistical data analysis and experience with statistical programs. Ability to program using data science programming languages. Expert understanding of cGMP regulations and/or business and documentation processes. Highly proficient in technical writing and technical presentations. Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Preferred Qualifications:
Expertise in cell therapy, immunotherapy, or viral vector manufacturing. Experience shaping and executing global strategy across multiple manufacturing sites. Prior involvement in global governance forums or steering committees. Familiarity with advanced statistical and QbD approaches for process lifecycle management. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. For more on benefits, please visit https://careers.bms.com/life-at-bms/. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
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Working with Us: Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. The Process Monitoring Systems Lead will be responsible for the establishment and maintenance of systems to support process data trending programs for the commercial and late-stage clinical vector products across the cell therapy network. This individual will be responsible for statistical process control program and continued process verification for the network. Key Responsibilities:
Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs. Serve as the interface for CMO sites, product teams and laboratories ensuring consistent data monitoring activities. In partnership with product and site teams execute end to end product robustness reviews. Promote innovative and efficient approaches to SPC and CPV based on risk-based elements and considerations unique to cell therapy production. Manage complex cross-functional projects/programs using project management techniques and tools. Partner with IT, MS&T, and AS&T to create and maintain required data structures or hierarchies. Train end users on process robustness systems and procedures. Qualifications & Experience:
Bachelor's degree or equivalent in relevant discipline with a minimum of 8-10 years of relevant experience. Expertise in statistical data analysis and experience with statistical programs. Ability to program using data science programming languages. Expert understanding of cGMP regulations and/or business and documentation processes. Highly proficient in technical writing and technical presentations. Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Preferred Qualifications:
Expertise in cell therapy, immunotherapy, or viral vector manufacturing. Experience shaping and executing global strategy across multiple manufacturing sites. Prior involvement in global governance forums or steering committees. Familiarity with advanced statistical and QbD approaches for process lifecycle management. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. For more on benefits, please visit https://careers.bms.com/life-at-bms/. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
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