Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic

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Department: Precision Medicine Bioanalysis & Translational Sciences (PMBATS)

Location: Lawrenceville NJ

Reports To: Director Lab Planning & Execution

Summary / Scope

At Bristol Myers Squibb we are inspired by a single vision transforming patients lives through science.

The Manager II Lab Planning & Operations will provide leadership and operational oversight for companion diagnostic (CDx) assay design development and clinical testing in a CLIA-certified environment directly supporting Phase 1/2 patient selection and stratification drug studies.

This role emphasizes immunohistochemistry (IHC) as the primary technology platform with additional background in NGS PCR/molecular diagnostics and flow cytometry as valuable complements. You will ensure compliance with FDA 21 CFR Part 820 IVDR CLIA CAP ISO13485 and ICH-GCP standards while driving Design Verification Validation Product Risk Management and Traceability Matrix execution.

This is a highly visible opportunity to bring accountability ownership and scientific excellence to a cutting-edge pipeline. Your work will directly influence how patients are selected for novel therapies helping deliver the right treatment to the right patient at the right time.

Key Responsibilities

Operational Leadership

• Serve as the primary operational lead for IHC-based CDx programs ensuring robustness and compliance across assay design validation and transfer.
• Lead complementary diagnostic efforts using NGS PCR and flow cytometry to support multi-platform precision medicine strategies.
• Oversee assay lifecycle management including Design Verification Validation Risk Management and Traceability Matrix implementation.
• Direct instrument qualification (IQ/OQ/PQ) capacity planning and readiness for clinical studies.
• Apply expertise in LIMS ELN and clinical data management systems to support regulatory submissions and study execution.

Project & CRO Management

• Act as the accountable owner for CRO central lab and diagnostic vendor partnerships; ensure timelines quality and deliverables are consistently achieved.
• Manage IHC-focused assay development timelines data/sample logistics and troubleshooting.
• Drive proactive risk identification mitigations and CAPA implementation.

Quality Management Systems

• Ensure adherence to FDA 21 CFR Part 820 (Design Control) Part 11 IVDR ICH-GCP and GLP standards.
• Support internal/external audits and regulatory submissions (CDx LDT IVDR filings).

Cross-Functional Collaboration

• Collaborate with scientific regulatory QA clinical IT finance and legal teams to align on CDx strategy and execution.
• Partner with translational medicine teams to integrate IHC and other diagnostic platforms into clinical protocols.
• Deliver timely and transparent updates to leadership and stakeholders demonstrating integrity and ownership.

Financial & Resource Planning

• Manage budgets staffing and forecasting for CLIA/CDx operations with emphasis on IHC capacity.
• Partner with leadership to guide capital investments in state-of-the-art IHC and diagnostic platforms.

Continuous Improvement & Innovation

• Champion best practices in IHC-based diagnostic validation while exploring complementary technologies (NGS PCR flow cytometry).
• Drive innovation through automation digital pathology and AI-enabled imaging solutions.
• Foster a culture of urgency accountability and inclusion to accelerate diagnostic readiness for patients.

Qualifications

Education & Experience

• Bachelors degree in a scientific/engineering discipline required; advanced degree (M.S./Ph.D./ MBA) strongly preferred.
• 8 years of experience in clinical diagnostics CDx development or regulated bioanalysis within pharma biotech or IVD settings.
• Hands-on expertise in IHC (required and primary focus); additional experience in NGS PCR and flow cytometry strongly preferred.
• Proven track record in CLIA lab operations assay validation design control and regulatory submissions.
• Familiarity with CRO/vendor management ligand-binding immunoassays and translational bioanalysis.

Skills & Competencies

• Strong knowledge of FDA 21 CFR Part 820 (QMSR) Part 11 CLIA CAP IVDR ISO13485 and ICH-GCP.
• Expertise in Design Verification Validation Product Risk Management and Traceability Matrices.
• Skilled in IHC assay transfer validation and operational readiness for clinical studies.
• Experience in instrument qualification (IQ/OQ/PQ) capacity analysis and lab planning.
• Excellent project management cross-functional alignment and vendor negotiation skills.
• Proficiency in QMS EDMS ELN LIMS and project management tools.
• PMP certification or equivalent training preferred.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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