Senior Manager, Process Monitoring Systems Lead

Bristol Myers Squibb

94d • $119,102 - $158,756

About The Position

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.

Requirements

• Bachelor’s degree or equivalent in relevant discipline with a minimum of 8-10 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.
• 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.

Nice To Haves

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees