Principal Scientist, Raw Materials CoE Strategy Lead

Merck; Rahway (NJ); On-site; USD 157,000 - 247,000; Full time

Job summary

Merck in Rahway, NJ seeks a Principal Scientist to lead the Raw Materials Center of Excellence strategy across clinical portfolios. You will set harmonized, risk-based testing strategies for raw materials, excipients, and packaging components, ensuring cGMP compliance and inspection readiness.

You will mentor scientists, collaborate with Quality, Procurement, and Pharmaceutical Sciences, and drive multi-year roadmaps with cross-functional teams in a matrix environment.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience.
• Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience.
• Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.

Responsibilities

• Define and drive the strategy, governance, and multi-year roadmap for the Raw Materials Center of Excellence.
• Establish science- and risk-based raw material control strategies to enable on-time, right-first-time clinical manufacture.
• Provide technical oversight of contract laboratories and lead investigations, deviations, and CAPAs.
• Review and approve GMP data, release specifications, reports, and SOPs; author CoE standards and governance documents.
• Serve as the raw material SME during audits and regulatory inspections.
• Monitor regulatory and industry trends; lead gap assessments and implementation plans.
• Champion operational excellence and data integrity through digital tools and innovative technologies.
• Partner with cross-functional teams to align an integrated raw material strategy across modalities.
• Mentor and develop scientists to build raw materials expertise within the CoE.

Skills

Raw Materials

Analytical Testing

GMP

ICH Guidelines

Regulatory Inspections

Strategic Planning

Cross-functional Leadership

Mentoring

Data Integrity

Education

PhD in Analytical Chemistry/ Biochemistry/ Pharmaceutical Sciences

Master’s in Analytical Chemistry/ Biochemistry/ Pharmaceutical Sciences

Bachelor’s in Analytical Chemistry/ Biochemistry/ Pharmaceutical Sciences

Job description

Merck in Rahway, NJ seeks a Principal Scientist to lead the Raw Materials Center of Excellence strategy across clinical portfolios. You will set harmonized, risk-based testing strategies for raw materials, excipients, and packaging components, ensuring cGMP compliance and inspection readiness.

You will mentor scientists, collaborate with Quality, Procurement, and Pharmaceutical Sciences, and drive multi-year roadmaps with cross-functional teams in a matrix environment.