Principal Scientist, Parenteral ExM MS&T
About The Position
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Opportunity We are looking for a dynamic and experienced Principal Scientist to join our External Manufacturing (ExM) Manufacturing Science & Technology (MS&T) team. In this high-impact role, you will serve as a critical technical leader, providing expert support and oversight for parenteral drug product manufacturing at Contract Manufacturing Organizations (CMOs) within North America.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, Biochemistry, Pharmacy, Microbiology, or a related pharmaceutical science is required; Master's or PhD strongly preferred.
- Experience requirements (depending on degree level): BS: 9–12 years of relevant experience, MS: 6–9 years of relevant experience, PhD: 4–6 years of relevant experience
- Recognized subject matter expert in sterile/parenteral manufacturing processes and associated global regulatory requirements (e.g., 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 tools such as Minitab or JMP; 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.
- Demonstrated experience with sterile drug product manufacturing operations
- Strategic and analytical thinker with strong problem-solving and rapid decision-making capabilities.
- Demonstrated 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.
- Comfortable managing multiple programs simultaneously in complex, ambiguous environments.
Responsibilities
- Act as Process Owner: Drive continuous process verification (CPV) and Operational Excellence (OPEX) initiatives at CMO sites, identifying and executing process robustness improvement projects to reduce supply risk.
- Be the Technical Point of Contact: Serve as the BMS Site Implementation Lead for CMO partners, including Person in Plant (PIP) support during technical transfers and commercial manufacturing activities.
- Lead Investigations: Lead root cause analysis, impact assessments, and corrective/preventive action (CAPA) development for out-of-trend or out-of-specification results and deviations in drug product manufacturing.
- Support Regulatory & CMC Activities: Contribute technical input to CMC documents, support responses to Global Health Authority queries, and assist during plant inspections.
- Drive Change Management: Lead and coordinate change requests and complex process deviations, sometimes across multiple sites or functions.
- Cross-Functional Collaboration: Represent MS&T on project teams, working closely with Quality Assurance, Global Procurement, Supply Chain, Supply Relationship Management, and Product Development.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Principal
