Bristol Myers Squibb
Overview
Join to apply for the
Manager II, Lab Planning & Operations
role at
Bristol Myers Squibb . Location: Lawrenceville, NJ. Department: Precision Medicine, Bioanalysis & Translational Sciences (PMBATS). Reports To: Director, Lab Planning & Execution. Employee Grade: EG-110. Summary / Scope: At Bristol Myers Squibb, we are inspired by a single vision – transforming patients' lives through science. The Manager II, Lab Planning & Operations provides 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. The 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. Complementary diagnostics: Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry to support multi-platform precision medicine strategies. Assay lifecycle management: Oversee Design Verification, Validation, Risk Management, and Traceability Matrix implementation. Instrument qualification and readiness: Direct instrument qualification (IQ/OQ/PQ), capacity planning, and readiness for clinical studies. Data management: Apply expertise in LIMS, ELN, and clinical data management systems to support regulatory submissions and study execution. Project & CRO Management
Accountable owner for CRO, central lab, and diagnostic vendor partnerships; ensure timelines, quality, and deliverables are 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
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. 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. Compensation & Benefits
The starting compensation range is listed for a full-time employee basis. Additional incentive cash and stock opportunities may be available based on eligibility. Benefits include medical, dental, vision, wellbeing programs, 401(k), short- and long-term disability, life insurance, paid holidays, vacation, volunteer days, parental and caregiver leave, adoption and surrogacy benefits, fertility benefits, tuition reimbursement, and a recognition program. Eligibility for specific benefits varies by location. On-site Protocol
BMS occupancy models determine where work is conducted. Roles may be site-essential (100% onsite), site-by-design (hybrid with at least 50% onsite), or field/remote-by-design with travel as required. Reasonable accommodations are available; contact adastaffingsupport@bms.com for accommodation inquiries. Equal Employment Opportunity statements and California-residents information are available at the links on careers.bms.com. Note
All information is subject to change. If you live in or work from Los Angeles County, additional information is provided on the California residents page.
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Join to apply for the
Manager II, Lab Planning & Operations
role at
Bristol Myers Squibb . Location: Lawrenceville, NJ. Department: Precision Medicine, Bioanalysis & Translational Sciences (PMBATS). Reports To: Director, Lab Planning & Execution. Employee Grade: EG-110. Summary / Scope: At Bristol Myers Squibb, we are inspired by a single vision – transforming patients' lives through science. The Manager II, Lab Planning & Operations provides 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. The 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. Complementary diagnostics: Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry to support multi-platform precision medicine strategies. Assay lifecycle management: Oversee Design Verification, Validation, Risk Management, and Traceability Matrix implementation. Instrument qualification and readiness: Direct instrument qualification (IQ/OQ/PQ), capacity planning, and readiness for clinical studies. Data management: Apply expertise in LIMS, ELN, and clinical data management systems to support regulatory submissions and study execution. Project & CRO Management
Accountable owner for CRO, central lab, and diagnostic vendor partnerships; ensure timelines, quality, and deliverables are 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
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. 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. Compensation & Benefits
The starting compensation range is listed for a full-time employee basis. Additional incentive cash and stock opportunities may be available based on eligibility. Benefits include medical, dental, vision, wellbeing programs, 401(k), short- and long-term disability, life insurance, paid holidays, vacation, volunteer days, parental and caregiver leave, adoption and surrogacy benefits, fertility benefits, tuition reimbursement, and a recognition program. Eligibility for specific benefits varies by location. On-site Protocol
BMS occupancy models determine where work is conducted. Roles may be site-essential (100% onsite), site-by-design (hybrid with at least 50% onsite), or field/remote-by-design with travel as required. Reasonable accommodations are available; contact adastaffingsupport@bms.com for accommodation inquiries. Equal Employment Opportunity statements and California-residents information are available at the links on careers.bms.com. Note
All information is subject to change. If you live in or work from Los Angeles County, additional information is provided on the California residents page.
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