Principal Scientist, Parenteral ExM MS&T

Bristol Myers Squibb seeks a Principal Scientist to lead manufacturing science and technology initiatives for parenteral drug products at external contract manufacturing organizations. The role involves process optimization, technical oversight, regulatory support, and cross-functional collaboration across North American CMO sites.

Responsibilities

• Drive continuous process verification and operational excellence initiatives at CMO sites to reduce supply risk
• Serve as BMS Site Implementation Lead and technical point of contact for CMO partners during transfers and manufacturing
• Lead root cause analysis, impact assessments, and corrective/preventive action development for manufacturing deviations
• Provide technical input to CMC documents, support regulatory queries, and assist during inspections
• Lead change management and coordinate complex process deviations across multiple sites and functions

Requirements

• Bachelor's degree in Chemical Engineering, Bioprocess Engineering, Pharmacy, or related pharmaceutical science; Master's or PhD preferred
• 9–12 years relevant experience (BS), 6–9 years (MS), or 4–6 years (PhD) in sterile/parenteral manufacturing
• Subject matter expertise in sterile drug product manufacturing, FDA cGMP, and global regulatory requirements
• Proficiency with statistical process analysis tools (Minitab, JMP); knowledge of DoE, QbD, and risk assessment frameworks
• Experience with formal risk assessment tools including pFMEA and Fishbone analysis
• Demonstrated ability to influence cross-functional stakeholders and manage complex, ambiguous programs
• Strong written and oral communication skills; approximately 20% travel required

Compensation: $122,110 - $147,970 base