Principal Scientist, Cleaning Verification Strategy Lead

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

Job summary

MSD in Rahway, NJ is seeking a Principal Scientist to serve as Strategy Lead for the Cleaning Verification Center of Excellence. You will define the strategy, harmonize approaches across small and large molecules, and drive development, validation, and lifecycle management of cleaning verification methods in a GMP environment.

The role partners with Analytical leadership and cross-functional teams to advance initiatives, ensure inspection readiness, and foster scientific excellence while

Qualifications

• PhD with at least 7 years of pharmaceutical industry experience.
• Master’s with at least 10 years of pharmaceutical industry experience.
• Bachelor’s with at least 12 years of pharmaceutical industry experience.
• Proven technical leadership in analytical cleaning verification/validation in a GMP setting.

Responsibilities

• Define and lead the Cleaning Verification CoE strategy and roadmap across programs and sites.
• Develop, validate, and transfer cleaning verification methods for timely drug substance/product release.
• Collaborate with Process Engineering, Clinical Manufacturing, and Quality to set science- and risk-based acceptance limits.
• Provide technical oversight on lab investigations, deviations, and CAPAs.
• Lead audits and regulatory inspections related to cleaning verification.
• Mentor scientists and build cleaning verification capability across the organization.

Skills

Analytical Chemistry

Analytical Method Development

Assay Development

Bioanalytical Analysis

Biochemistry

Cleaning Validations

Regulatory Inspections

Small Molecules

Large Molecules

Education

PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields

Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields

Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields

Job description

MSD in Rahway, NJ is seeking a Principal Scientist to serve as Strategy Lead for the Cleaning Verification Center of Excellence. You will define the strategy, harmonize approaches across small and large molecules, and drive development, validation, and lifecycle management of cleaning verification methods in a GMP environment.

The role partners with Analytical leadership and cross-functional teams to advance initiatives, ensure inspection readiness, and foster scientific excellence while