Senior PMO Lead: Bioanalysis & Translational Medicine

Bristol Myers Squibb; Princeton (NJ); On-site; USD 157,000 - 190,000; Full time

Job summary

Bristol Myers Squibb in Princeton, NJ seeks Associate Director, PMO to lead program management and operations for internal CLIA lab and Bioanalysis Biotherapeutics & Cell Therapy. You will drive design control, risk management, and cross-functional execution in a regulated environment.

The role collaborates with Translational Medicine, Clinical Pharmacology, Regulatory Affairs, Quality, and Clinical Operations to deliver on-time, on-budget results while maintaining inspection readiness.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline is required.
• MS or PhD preferred for advanced expertise.
• Minimum 8 years of combined laboratory operations and program management experience in regulated industries.
• Experience in CLIA‑certified and/or GxP environments and audit readiness.
• Knowledge of FDA 21 CFR 820 (QSR), EU IVDR, ISO 13485 and design control.
• PMP certification is preferred.

Responsibilities

• Lead design, development, validation, qualification, and technology transfer across programs.
• Implement design control per FDA 21 CFR 820 (QSR), EU IVDR, ISO 13485 for lifecycles.
• Manage internal IHC and molecular IUO assay programs (qPCR, ddPCR, NGS).
• Own program planning, timelines, budgets for CLIA lab operations.
• Coordinate with Precision Medicine, Clinical Pharmacology, Translational Medicine, and Regulatory/Quality teams.
• Lead third‑party risk management and supplier quality oversight.
• Ensure GLP, GCP, CLIA, CAP compliance and audit readiness.
• Represent PM&O on governance and steering committees.
• Track metrics: turnaround time, ELN usage, calibration, and LIMS data.
• Identify and mitigate risks across operations and external partnerships.

Skills

Program management

Regulatory compliance

Cross-functional leadership

Systems engineering

Risk management

Education

Bachelor’s degree in science or engineering

MS or PhD preferred

Tools

Microsoft Office

Project

Excel

Teams

Visio

SAP

Ariba

LIMS

Job description

Bristol Myers Squibb in Princeton, NJ seeks Associate Director, PMO to lead program management and operations for internal CLIA lab and Bioanalysis Biotherapeutics & Cell Therapy. You will drive design control, risk management, and cross-functional execution in a regulated environment.

The role collaborates with Translational Medicine, Clinical Pharmacology, Regulatory Affairs, Quality, and Clinical Operations to deliver on-time, on-budget results while maintaining inspection readiness.