Lead, Regulated Lab Projects & Biomarker Programs

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 140,000 - 180,000; Full time

Job summary

Bristol Myers Squibb in Princeton, NJ seeks an Associate Director of Project Management & Operations to drive the program management framework for its CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs.

You will oversee study design, verification, validation, and transfer of investigational biomarker assays for early-stage Phase I/II studies, ensuring on-time delivery and audit readiness.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline.
• 8+ years in regulated pharma/biotech operations and program management.
• Experience with CLIA/GxP, 21 CFR 820, IVDR, and ISO 13485 is preferred.

Responsibilities

• Lead program management for regulated bioanalytical studies and technology transfer.
• Ensure alignment with FDA, EU, and ISO requirements across assays.
• Oversee budgets, timelines, and cross-functional execution.

Skills

Laboratory operations

Program management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

MS or PhD preferred

Tools

LIMS

ELN

qPCR

ddPCR

NGS

Job description

Bristol Myers Squibb in Princeton, NJ seeks an Associate Director of Project Management & Operations to drive the program management framework for its CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs.

You will oversee study design, verification, validation, and transfer of investigational biomarker assays for early-stage Phase I/II studies, ensuring on-time delivery and audit readiness.