My Next Stage
Senior Manager, Process Monitoring Systems Lead
My Next Stage, Madison, New Jersey, us, 07940
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.
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. The lead will represent the process monitoring and investigations function in department and network meetings enabling a consistent approach and transparency of information flow across the organization. The person will collaborate with SMEs, user groups, quality groups, and other stakeholders to support complex trend deviations and CAPAs responsible for process monitoring (CPV) related activities. Key Responsibilities: Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs creating standard work for all manufacturing sites and seamless integration of cross site data trending to enable root cause analysis, CAPA identification, and process monitoring documentation. 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 by analyzing, vector process and analytical data. 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 that is appropriate for the given project. Partner with IT, MS&T, and AS&T to create and maintain required data structures or hierarchies to include new molecule/modality in new or existing sites 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. Masters preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience 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. Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency, teamwork, and presentation skills. Strong interpersonal skills required to work with teams in different functions and organizations. Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects. Detail oriented with excellent verbal and written communication skills. 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. A degree in data analytics or relevant experience in data analytics for bioprocess applications. Compensation Overview: The starting compensation range for this role is $119,102 - $144,324 for Madison - Giralda - NJ - US and $131,012 - $158,756 for Seattle - WA. Additional incentive cash and stock opportunities may be available. Benefits: 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. This includes medical, pharmacy, dental and vision care, wellbeing support, financial well-being resources, and a 401(K). We also offer work-life programs such as paid national holidays, up to 120 hours of paid vacation, and summer hours flexibility. Equal Employment Opportunity: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. We will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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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. The lead will represent the process monitoring and investigations function in department and network meetings enabling a consistent approach and transparency of information flow across the organization. The person will collaborate with SMEs, user groups, quality groups, and other stakeholders to support complex trend deviations and CAPAs responsible for process monitoring (CPV) related activities. Key Responsibilities: Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs creating standard work for all manufacturing sites and seamless integration of cross site data trending to enable root cause analysis, CAPA identification, and process monitoring documentation. 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 by analyzing, vector process and analytical data. 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 that is appropriate for the given project. Partner with IT, MS&T, and AS&T to create and maintain required data structures or hierarchies to include new molecule/modality in new or existing sites 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. Masters preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience 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. Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency, teamwork, and presentation skills. Strong interpersonal skills required to work with teams in different functions and organizations. Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects. Detail oriented with excellent verbal and written communication skills. 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. A degree in data analytics or relevant experience in data analytics for bioprocess applications. Compensation Overview: The starting compensation range for this role is $119,102 - $144,324 for Madison - Giralda - NJ - US and $131,012 - $158,756 for Seattle - WA. Additional incentive cash and stock opportunities may be available. Benefits: 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. This includes medical, pharmacy, dental and vision care, wellbeing support, financial well-being resources, and a 401(K). We also offer work-life programs such as paid national holidays, up to 120 hours of paid vacation, and summer hours flexibility. Equal Employment Opportunity: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. We will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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