Manager, Lab Planning & Operations

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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, ISO13485, 21 CFR 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.

QUALIFICATIONS

Education & Experience:

• Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred.

• Minimum 6 years of ind