Principal Scientist, Manufacturing Technology

Responsibilities

• Lead complex technical transfers to support BMS business objectives
• Influence technical direction for biologics drug substance manufacturing across various stages
• Drive decisions for highly complex or novel problems in biologics manufacturing
• Support technical aspects of site regulatory inspections, including Pre-Approval Inspections (PAI)
• Ensure timely delivery of projects across technical transfer, process validation, and post-approval changes
• Drive effective working relationships with Quality, Operations, Engineering, and Regulatory teams

Requirements

• Bachelor's degree in engineering or science with 9-12 years of experience, Master's with 6-9 years, or PhD with 4-6 years
• Technical execution experience in technology transfer and Process Performance Qualification
• Knowledge of global regulatory requirements for biologics drug substance processes
• Thorough understanding of quality systems, Quality by Design, and validation principles
• Excellent communication, presentation, and stakeholder management skills
• Strong analytical, technical, and strategic thinking abilities
• Proficiency in project management systems and tools

About the Company

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail against serious diseases.