Senior Manager, Process Monitoring Systems Lead

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.

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: Madison - Giralda - NJ - US: $119,102 - $144,324 Seattle - WA: $131,012 - $158,756 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. 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. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. 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. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.