Senior Manager, Process Engineer/Biostatistician

Role Summary

Senior Manager, Process Engineer/Biostatistician at Bristol Myers Squibb. Lead the establishment and maintenance of data systems to support process data trending for vector products across the cell therapy network. Drive statistical process control, continued process verification, and cross-site data integration to enable root cause analysis and CAPA identification.

Responsibilities

• Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs, establishing standard work for all manufacturing sites and seamless 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 appropriate for the 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

• Bachelor's degree or equivalent in relevant discipline with 8‚Äì10 years of relevant experience; master's preferred. Time spent in advanced degree programs may be considered as equivalent experience.
• Expertise in statistical data analysis and experience with statistical programs such as Discoverant, JMP, etc.
• Ability to program using data science languages such as Python, R; this is a plus.
• Expert understanding of cGMP regulations and/or business and documentation processes.
• Strong technical writing and presentations skills; ability to contribute to external/internal scientific community.
• Ability to work in a fast-paced matrix environment with excellent communication, sense of urgency, teamwork, and presentation skills.
• Strong interpersonal skills to work with cross-functional teams; proven ability to meet deadlines and prioritize multiple projects.
• Detail-oriented with excellent verbal and written communication skills.

Skills

• Statistical data analysis
• Vector SPC and CPV programs
• Data governance and data structures
• Cross-functional project management
• Technical writing and presentations

Education

• Bachelor's degree required; Master's degree preferred in a relevant field.