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

1010 Celgene - Summit (Corp); Princeton (NJ); Sur place; USD 157 000 - 190 000; Plein temps

Résumé du poste

Bristol Myers Squibb is seeking an Associate Director of Project Management & Operations (PM&O) to lead the program management framework for internal CLIA laboratory and biomarker assay programs.

You will align with FDA QSR, EU IVDR, ISO 13485 and ensure on-time, on-budget, audit-ready results through matrixed collaboration across Translational Medicine, Clinical Pharmacology, Quality, and Regulatory Affairs.

Qualifications

• Bachelor’s degree in science or engineering required.
• 8+ years of combined lab operations and program management experience.
• Experience in CLIA/GxP-regulated lab environments.
• Knowledge of FDA 21 CFR 820 (QSR), EU IVDR, and ISO 13485.
• Experience with IHC or molecular diagnostics (qPCR/ddPCR/NGS).
• Strong cross-functional collaboration and communication skills.
• PMP certification preferred.
• Willingness to travel occasionally.

Responsabilités

• Lead design control practices across assay lifecycles.
• Manage program planning, timelines, resources, and budgets.
• Oversee internal CLIA lab and external biomarker programs.
• Coordinate with Translational Medicine, Clinical Pharmacology, Regulatory Affairs.
• Drive risk management and audit readiness.
• Represent PMO on governance committees.

Connaissances

Project management

Regulatory knowledge

Cross-functional leadership

Financial management

Communication skills

Formation

Bachelor’s degree in science/engineering

Outils

Project

Excel

SAP

Ariba

LIMS

Visio

Description du poste

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

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&V), 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 escalation 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&V), 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.

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin 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 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 https://careers.bms.com/washington-state-fair-chance-act/.