Principal Scientist, Parenteral ExM MS&T

At Bristol Myers Squibb our employees often ask Who are you working fora 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) 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.

• 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.

• Bachelors degree in Chemical Engineering Mechanical Engineering Bioprocess Engineering Biochemistry Pharmacy Microbiology or a related pharmaceutical science is required; Masters or PhD strongly preferred.
• Experience requirements (depending on degree level): BS: 912 years of relevant experience MS: 69 years of relevant experience PhD: 46 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.

This role requires approximately 20% travel

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including 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 also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

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