Manager II, Lab Planning & Operations

Celgene • Princeton, NJ

87d • $123,670 - $149,855 • Hybrid

About The Position

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.

Requirements

• Bachelor's 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.

Nice To Haves

• PMP certification or equivalent training preferred.

Responsibilities

• 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.
• 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.
• 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).
• 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.
• 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.
• 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.

Benefits

• 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 Year's 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree