Associate Director, Project Management & Operations – (Translational Medicine, CLIA, & Bioanalysis)

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Associate Director, Project Management & Operations (PM&O) leads the program management and operational framework supporting BMS’s internal CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs. This role enables internal and external bioanalysis studies and supports the development, verification, validation, and transfer of investigational biomarker assays used in early-stage Phase I/II patient stratification studies. The Associate Director brings systems engineering, design control, and operational rigor to regulated laboratory and assay programs, including alignment with FDA 21 CFR 820 (QSR), EU IVDR, ISO 13485, CLIA, GLP, and GCP requirements. The role partners closely with Translational Medicine, Clinical Pharmacology, Precision Medicine, Program Management, Regulatory Affairs, Quality, and Clinical Operations to translate complex cross-functional programs into on‑time, on‑budget, and audit‑ready results. The successful candidate will demonstrate strong ownership and accountability, clear communication, disciplined risk management, financial and operational acumen, and the ability to lead complex programs across a highly matrixed organization.

Key Responsibilities

• Serve as process lead for assay and biomarker design, development, validation, qualification, and technology transfer, driving project plans, timelines, resourcing, and cross‑functional execution across internal and external Bioanalysis Biotherapeutics & Cell Therapy programs and early‑stage Phase I/II patient stratification studies.
• Drive design control practices across the assay lifecycle in accordance with FDA 21 CFR 820 (QSR), EU IVDR, and ISO 13485, including systems engineering, design inputs and outputs, verification and validation (V&A), risk management, and design transfer to production.
• Lead project and program management for internal IHC and molecular investigational use only (IUO) assay programs, including qPCR, ddPCR, Next‑Generation Sequencing (NGS), and Bioanalysis Biotherapeutics & Cell Therapy biomarker programs.
• Own program planning, timelines, resource management, and CapEx/OpEx budgets for internal BMS CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy operations, including project intake and governance.
• Partner with Precision Medicine, Clinical Pharmacology, Translational Medicine, Program Management, Regulatory Affairs, Quality, and Clinical Operations to ensure alignment with clinical protocols, regulatory requirements, and operational priorities.
• Lead third‑party risk management (TPRM) and supplier quality management (SQM) for external vendors, CROs, and assay and biomarker partners, including scope definition, contracting, performance oversight, issue resolution, compliance, and budget accountability.
• Strengthen program and laboratory compliance with applicable GLP, GCP, CLIA, CAP, and other regulatory requirements and lead inspection readiness for internal and external audits, State inspections, CAP/CLIA inspections, and Health Authority inspections.
• Represent PM&O on governance and steering committees supporting the internal BMS CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs, driving risk assessments, vendor selection, and strategic decision‑making.
• Own systems, processes, and reporting for key laboratory operational and compliance metrics, including turnaround time, pricing, Electronic Lab Notebook (ELN) usage, equipment calibration and maintenance, temperature monitoring, and LIMS/data management.
• Proactively identify, assess, mitigate, and reconcile risks across laboratory operations, assay programs, external partnerships, timelines, quality, budget, and compliance.

Qualifications & Experience

• Bachelor’s degree in a scientific or engineering discipline required; MS or Ph.D. preferred.
• Minimum of 8 years of combined laboratory operations and program/project management experience within the pharmaceutical, biotechnology, diagnostics, or related regulated industry.
• Experience working within or overseeing CLIA‑certified and/or GxP‑regulated laboratory environments, including equipment compliance, resource and capacity planning, laboratory operations, and audit readiness.
• Deep knowledge of design control and systems engineering principles aligned with FDA 21 CFR 820 (QSR), EU IVDR, and ISO 13485, including design inputs/outputs, verification and validation (V&A), risk management, and design transfer to production.
• Experience applying design control principles to investigational assays, early‑stage Phase I/II assay development, and/or IVD device development.
• Experience with IHC and/or molecular diagnostic technologies such as qPCR, ddPCR, PCR, or NGS.
• Experience within an IHC or molecular diagnostic manufacturer, PCR/NGS manufacturing organization, or comparable regulated device/IVD environment strongly preferred.
• Demonstrated understanding of GLP, GCP, CLIA, CAP, and other applicable regulatory and compliance requirements, with experience maintaining inspection‑ and audit‑ready programs.
• Proven ability to lead complex, cross‑functional programs and influence stakeholders across Translational Medicine, Clinical Pharmacology, Precision Medicine, Program Management, Regulatory Affairs, Quality, Clinical Operations, or comparable functions.
• Strong ownership and accountability for program outcomes, with demonstrated ability to independently manage timelines, quality, deliverables, and competing priorities in a fast‑paced, matrixed environment.
• Strong written and verbal communication skills, including the ability to translate complex scientific, technical, operational, and regulatory information into clear recommendations for senior leadership.
• Experience managing external vendors, CROs, and diagnostic partners through formal TPRM and SQM processes, including contracting, performance oversight, compliance accountability, and issue resolution.
• Strong understanding of project financial management, including budgeting, expenditures, CapEx/OpEx planning, contract development, and identification of cost efficiencies.
• Demonstrated ability to proactively identify and mitigate operational, technical, financial, vendor, and compliance risks.
• Proficiency with project management and information technology systems such as Microsoft Office, Project, Excel, Teams, Visio, SAP, Ariba, and LIMS.
• PMP certification preferred.
• Occasional travel may be required to support laboratory, CRO, and vendor oversight.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Princeton - NJ - US: $156,890 - $190,117

The starting pay range(s) listed above is for full‑time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non‑exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time‑off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1608166 : Associate Director, Project Management & Operations – (Translational Medicine, CLIA, & Bioanalysis)