Bristol Myers Squibb
Senior Manager, Process Monitoring Systems Lead
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Manager, Process Monitoring Systems Lead
Join Bristol Myers Squibb to lead the establishment and maintenance of systems supporting process data trending across our commercial and late‑stage clinical vector products in the cell therapy network.
Working with Us Challenging. Meaningful. Life‑changing. That’s what you can expect at Bristol Myers Squibb. Here, uniquely interesting work happens daily, from optimizing production lines to breakthroughs in cell therapy. You’ll grow through opportunities uncommon in scale and scope, alongside high‑achieving teams.
Key Responsibilities
Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs, integrating cross‑site data trending for 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.
Partner with product and site teams to 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 unique to cell‑therapy production.
Manage complex cross‑functional projects/programs using appropriate project‑management techniques and tools.
Collaborate 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 in a relevant discipline; 8‑10 years of relevant experience (Masters preferred, but not required). Advanced degree programs may be considered as equivalent experience.
Expertise in statistical data analysis and experience with statistical programs such as Discoverant, JMP, etc.
Programming proficiency in data science languages such as Python, R, etc. is a plus.
Deep understanding of cGMP regulations and/or business and documentation processes.
Highly proficient in technical writing and technical presentations.
Self‑driven, performance‑oriented, fast‑paced matrix environment with excellent communication, writing, sense of urgency, teamwork, and presentation skills.
Strong interpersonal skills to work with teams across functions and organizations.
Demonstrated ability to work effectively 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.
Degree or relevant experience in data analytics for bioprocess applications.
Compensation Overview Devens, MA: US $127,440‑$154,428 Madison – Giralda, NJ: US $119,102‑$144,324 Seattle, WA: US $131,012‑$158,756
Starting compensation ranges are listed for full‑time employees. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final compensation will be decided based on demonstrated experience.
Benefits Bristol Myers Squibb offers competitive medical, pharmacy, dental, and vision care, wellbeing support, 401(K) and financial protection benefits, paid national holidays, optional holidays, up to 120 hours of paid vacation, volunteer time, sick time, and more. For details, visit https://careers.bms.com/life-at-bms/.
Equal Employment Opportunity We are committed to creating a diverse workforce. BMS is an equal‑employment opportunity employer, and we celebrate the differences among our employees and the communities we serve. For our complete EEO statement, visit https://careers.bms.com/eeo-accessibility.
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Working with Us Challenging. Meaningful. Life‑changing. That’s what you can expect at Bristol Myers Squibb. Here, uniquely interesting work happens daily, from optimizing production lines to breakthroughs in cell therapy. You’ll grow through opportunities uncommon in scale and scope, alongside high‑achieving teams.
Key Responsibilities
Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs, integrating cross‑site data trending for 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.
Partner with product and site teams to 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 unique to cell‑therapy production.
Manage complex cross‑functional projects/programs using appropriate project‑management techniques and tools.
Collaborate 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 in a relevant discipline; 8‑10 years of relevant experience (Masters preferred, but not required). Advanced degree programs may be considered as equivalent experience.
Expertise in statistical data analysis and experience with statistical programs such as Discoverant, JMP, etc.
Programming proficiency in data science languages such as Python, R, etc. is a plus.
Deep understanding of cGMP regulations and/or business and documentation processes.
Highly proficient in technical writing and technical presentations.
Self‑driven, performance‑oriented, fast‑paced matrix environment with excellent communication, writing, sense of urgency, teamwork, and presentation skills.
Strong interpersonal skills to work with teams across functions and organizations.
Demonstrated ability to work effectively 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.
Degree or relevant experience in data analytics for bioprocess applications.
Compensation Overview Devens, MA: US $127,440‑$154,428 Madison – Giralda, NJ: US $119,102‑$144,324 Seattle, WA: US $131,012‑$158,756
Starting compensation ranges are listed for full‑time employees. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final compensation will be decided based on demonstrated experience.
Benefits Bristol Myers Squibb offers competitive medical, pharmacy, dental, and vision care, wellbeing support, 401(K) and financial protection benefits, paid national holidays, optional holidays, up to 120 hours of paid vacation, volunteer time, sick time, and more. For details, visit https://careers.bms.com/life-at-bms/.
Equal Employment Opportunity We are committed to creating a diverse workforce. BMS is an equal‑employment opportunity employer, and we celebrate the differences among our employees and the communities we serve. For our complete EEO statement, visit https://careers.bms.com/eeo-accessibility.
#J-18808-Ljbffr