Manager, Lab Planning & Operations - Princeton, NJ

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Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.

SUMMARY/SCOPE

The Manager Lab Planning & Operations plays a critical role in supporting the execution of bioanalytical and Companion Diagnostics (CDx) programs within the PMBATS department. You will drive operational excellence for regulated bioanalytical studies and CDx development ensuring high quality compliance and timely delivery of internal and outsourced projects. This role coordinates cross-functional activities manages project timelines and deliverables supports resource and budget planning and ensures adherence to regulatory standards (GLP CLIA CAP ISOCFR Part 11 QMSR IVDR).

You will lead project coordination for clinical bioanalytical studies including oversight of critical reagents assay timelines and deliverables working closely with external CROs and internal cross-functional teams.

KEY RESPONSIBILITIES

Project Operations

Lead and coordinate regulated bioanalytical and CDx studies including CRO oversight assay transfer and validation sample/data logistics and discrepancy reconciliation to ensure timely compliant execution.

Provide bioanalytical project management for clinical studies managing critical reagents and timelines for deliverables.

Monitor operational risks and deviations and lead implementation of corrective and preventive actions (CAPAs) in collaboration with quality teams.

Cross-Functional Coordination

Work collaboratively with scientific technical quality regulatory IT finance and legal teams to drive successful lab operations and study execution.

Support the development and management of contracts and scope-of-work with research collaborators and external service providers.

Vendor & CRO Oversight

Serve as the primary liaison with CROs and external partners managing study milestones deliverables and compliance with BMS quality systems and regulatory standards.

Compliance & Quality

Collaborate with the Lab Compliance team to maintain personnel information training records and department SOPs.

Support training program execution for the bioanalysis team ensuring training compliance is maintained tracked and audit-ready.

Coordinate SOP lifecycle management including drafting reviewing updating and routing SOPs related to bioanalysis and CDx operations to ensure compliance with internal document control policies.

Documentation & Archival

Maintain and oversee archival processes and systems for submission maintenance and retrieval of documentation under GLP GCP 21 CFR Part 11 and internal SOPs.

Ensure version control traceability and long-term accessibility of critical documentation such as validation data study reports assay protocols and SOPs.

Financial & Resource Planning

Assist in planning and tracking of project budgets resource allocation and expenses in alignment with operational needs.

Project Reporting

Prepare and deliver operational updates and project status reports for internal leadership and cross-functional stakeholders.

Continuous Improvement

Champion best practices in lab operations and project management to drive continuous improvement and efficiency.