Principal Scientist, Parenteral ExM MS&T

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 122,000 - 148,000; Full time

Benefits offered by this job

Flexible Time Off

Job summary

Bristol Myers Squibb in New Jersey is seeking a Principal Scientist to lead external manufacturing support for parenteral drug products. You will drive CPV and OPEX initiatives at CMOs, act as the site implementation lead for technology transfers, and guide investigations and CAPA for deviations.

You will also contribute to CMC documentation and regulatory responses while coordinating change requests across multiple sites and functions.

Qualifications

• Broadened knowledge of sterile/parenteral manufacturing and regulatory requirements.
• Experience in CPV, change management, and risk assessment.
• Strong collaboration with QA, procurement, and product development.

Responsibilities

• Act as Process Owner: drive CPV and OPEX at CMO sites to improve process robustness.
• Serve as Technical Point of Contact for PIP transfers and commercial manufacturing.
• Lead investigations and CAPA for out-of-trend results and deviations.
• Contribute technical input to CMC documents and regulatory responses.
• Coordinate change requests and complex deviations across sites.
• Represent MS&T on cross-functional project teams with QA and Supply Chain.

Skills

Process Owner

OPEX

CAPA

PIP support

Statistical analysis

GxP & cGMP

Education

Bachelor's in Chemical Engineering

Master's or PhD preferred

Tools

Minitab

JMP

DoE

QbD

pFMEA

Ishikawa

Job description

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.

What You'll Do

• - 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.

Education & Experience

• - 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

Technical Skills & Expertise

• - 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

Leadership & Soft Skills

• - 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.

Travel Requirements

This role requires approximately 20% travel

Compensation Overview:
New Brunswick - NJ - US: $122,110 - $147,970

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 Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How 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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606602 : Principal Scientist, Parenteral ExM MS&T