Principal Scientist, Parenteral ExM MS&T

Bristol Myers Squibb • New Brunswick, NJ

2d • $122,110 - $147,970

About The Position

Bristol Myers Squibb is seeking a Principal Scientist for its External Manufacturing (ExM) Manufacturing Science & Technology (MS&T) team. The role provides technical leadership and oversight for parenteral drug product manufacturing at contract manufacturing organizations (CMOs) in North America. The Principal Scientist serves as a process owner and technical point of contact for CMO partners, supporting technical transfers and commercial manufacturing. The position also leads investigations and change management, contributes to regulatory and CMC activities, and represents MS&T in cross-functional project teams. Approximately 20% travel is required.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, Biochemistry, Pharmacy, Microbiology, or a related pharmaceutical science.
• Relevant experience requirements vary by degree: 9–12 years with a BS, 6–9 years with an MS, or 4–6 years with a PhD.
• Recognized subject matter expertise in sterile/parenteral manufacturing processes and associated global regulatory requirements, such as FDA cGMP.
• In-depth knowledge of engineering, analytical, and regulatory (cGMP, EHS) aspects of drug product manufacturing, validation, and quality systems.
• Strong background in statistical process analysis, including proficiency with Minitab or JMP.
• Demonstrated experience with sterile drug product manufacturing operations.
• Strong problem-solving and rapid decision-making capabilities, with strategic and analytical thinking.
• Ability to influence without authority and build alignment across diverse, cross-functional, and multicultural stakeholders.
• Excellent written and oral communication skills, including the ability to translate complex technical issues into clear business impact and solutions.
• Ability to manage multiple programs simultaneously in complex, ambiguous environments.
• Willingness to travel approximately 20%.

Nice To Haves

• Master's degree or PhD.
• Familiarity with Design of Experiments (DoE), Quality by Design (QbD), and Risk Assessment frameworks.
• Experience with formal risk assessment tools such as pFMEA and Ishikawa (Fishbone) analysis.

Responsibilities

• Drive continuous process verification (CPV) and Operational Excellence (OPEX) initiatives at CMO sites, identifying and executing process robustness improvement projects to reduce supply risk.
• Serve as the BMS Site Implementation Lead for CMO partners, including providing Person in Plant (PIP) support during technical transfers and commercial manufacturing activities.
• Lead root cause analysis, impact assessments, and corrective and preventive action (CAPA) development for out-of-trend or out-of-specification results and drug product manufacturing deviations.
• Contribute technical input to CMC documents, support responses to Global Health Authority queries, and assist during plant inspections.
• Lead and coordinate change requests and complex process deviations, sometimes across multiple sites or functions.
• Represent MS&T on project teams and collaborate with Quality Assurance, Global Procurement, Supply Chain, Supply Relationship Management, and Product Development.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays each year for eligible employees.
• For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval, and 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal