Bristol Myers Squibb
Associate Director, Cell Therapy Robustness Process Monitoring Systems Lead
Bristol Myers Squibb, Seattle, Washington, us, 98127
Associate Director, Cell Therapy Robustness 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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. Position Summary
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 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 DP SPC and CPV program creating standard work for all manufacturing sites and seamless integration of cross site data, trending to enable root cause analysis, CAPA identification, and documentation. Serve as the interface between sites, product teams and laboratories ensuring consistent data monitoring activities. In partnership with product and site teams execute 'end to end' product robustness reviews that integrate DP, analytical and vector monitoring programs. Promote innovative and efficient approaches 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 that is appropriate for the given project. Train end users on process robustness systems and procedures. Qualifications & Experience
Bachelor's degree or equivalent in relevant discipline with a minimum of 10 years of relevant experience. Masters preferred (but not required). Expertise in statistical data analysis and experience with statistical programs such as Discoverant, JMP, etc. Ability to program using data science programming languages such as Python, R, etc., is a plus. Expert understanding of cGMP regulations and/or business and documentation processes. Highly proficient in technical writing and technical presentations, contributing to broader external and internal scientific community as appropriate. Proficient in project and portfolio management skills. 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. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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. Position Summary
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 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 DP SPC and CPV program creating standard work for all manufacturing sites and seamless integration of cross site data, trending to enable root cause analysis, CAPA identification, and documentation. Serve as the interface between sites, product teams and laboratories ensuring consistent data monitoring activities. In partnership with product and site teams execute 'end to end' product robustness reviews that integrate DP, analytical and vector monitoring programs. Promote innovative and efficient approaches 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 that is appropriate for the given project. Train end users on process robustness systems and procedures. Qualifications & Experience
Bachelor's degree or equivalent in relevant discipline with a minimum of 10 years of relevant experience. Masters preferred (but not required). Expertise in statistical data analysis and experience with statistical programs such as Discoverant, JMP, etc. Ability to program using data science programming languages such as Python, R, etc., is a plus. Expert understanding of cGMP regulations and/or business and documentation processes. Highly proficient in technical writing and technical presentations, contributing to broader external and internal scientific community as appropriate. Proficient in project and portfolio management skills. 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. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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