Principal Scientist, Raw Materials CoE Strategy Lead

MSD

Rahway (NJ)

On-site

USD 157,000 - 247,000

Full time

3 days ago

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Job summary

MSD in Rahway, NJ is looking for a Principal Scientist to define and lead the Raw Materials Center of Excellence strategy. You will establish harmonized, science- and risk-based control and release testing across our clinical portfolio including small molecules, biologics, and vaccines.

The role requires serving as the technical authority on raw materials, ensuring cGMP compliance, inspection readiness, and alignment with GMPs, ICH, USP/NF, and FDA guidelines while mentoring scientists and

Qualifications

PhD/Master's/Bachelor's with extensive pharma industry experience as stated.
Knowledge of GMPs, ICH, USP/NF and FDA guidance.
Experience leading technical strategy in a matrix organization.

Responsibilities

Define and drive multi-year CoE strategy and roadmaps for raw materials.
Establish science- and risk-based control strategies and reduced testing programs.
Provide technical oversight of contract laboratories and CAPAs.
Review GMP data, release specs, and SOPs; author CoE governance documents.
Serve as raw material SME during audits and regulatory inspections.
Monitor regulatory trends and lead gap assessments and plans.
Champion operational excellence via digital tools while ensuring data integrity.
Mentor scientists and partner with cross-functional stakeholders to align strategies.