About this role
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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.
Additional Qualifications/Responsibilities
What We're Looking For
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
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
New Brunswick - NJ - US: $122,110 - $147,970