Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic
Bristol-Myers Squibb
Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic
Job Description
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. 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. 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. Manage IHC-focused assay development timelines, data/sample logistics, and troubleshooting. 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. 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.
Key Responsibilities
- Serve as the primary operational lead for IHC-based CDx programs
- Ensure robustness and compliance across assay design, validation, and transfer
- Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry
- 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
- Manage IHC-focused assay development timelines, data/sample logistics, and troubleshooting
- 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
Required Qualifications
- Bachelor's degree in a scientific/engineering discipline
- + years of experience in clinical diagnostics, CDx development, or regulated bioanalysis within pharma, biotech, or IVD settings
- Hands-on expertise in IHC
Preferred Qualifications
- Advanced degree (M.S./Ph.D./MBA)
- Additional experience in NGS, PCR, and flow cytometry
- Familiarity with CRO/vendor management, ligand-binding immunoassays, and translational bioanalysis
- PMP certification or equivalent training
Skills Required
- 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
Benefits & Perks
- 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
- Summer hours flexibility
Locations
- Princeton NJ, United States
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong knowledge of FDA 21 CFR Part 820 (QMSR), Part 11, CLIA, CAP, IVDR, ISO13485, and ICH-GCPintermediate
- Expertise in Design Verification, Validation, Product Risk Management, and Traceability Matricesintermediate
- Skilled in IHC assay transfer, validation, and operational readiness for clinical studiesintermediate
- Experience in instrument qualification (IQ/OQ/PQ), capacity analysis, and lab planningintermediate
- Excellent project management, cross-functional alignment, and vendor negotiation skillsintermediate
- Proficiency in QMS, EDMS, ELN, LIMS, and project management toolsintermediate
Required Qualifications
- Bachelor's degree in a scientific/engineering discipline (experience)
- + years of experience in clinical diagnostics, CDx development, or regulated bioanalysis within pharma, biotech, or IVD settings (experience)
- Hands-on expertise in IHC (experience)
Preferred Qualifications
- Advanced degree (M.S./Ph.D./MBA) (experience)
- Additional experience in NGS, PCR, and flow cytometry (experience)
- Familiarity with CRO/vendor management, ligand-binding immunoassays, and translational bioanalysis (experience)
- PMP certification or equivalent training (experience)
Responsibilities
- Serve as the primary operational lead for IHC-based CDx programs
- Ensure robustness and compliance across assay design, validation, and transfer
- Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry
- 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
- Manage IHC-focused assay development timelines, data/sample logistics, and troubleshooting
- 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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Answer 10 quick questions to check your fit for Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic @ Bristol-Myers Squibb.
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Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic
Bristol-Myers Squibb
Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic
Job Description
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. 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. 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. Manage IHC-focused assay development timelines, data/sample logistics, and troubleshooting. 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. 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.
Key Responsibilities
- Serve as the primary operational lead for IHC-based CDx programs
- Ensure robustness and compliance across assay design, validation, and transfer
- Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry
- 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
- Manage IHC-focused assay development timelines, data/sample logistics, and troubleshooting
- 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
Required Qualifications
- Bachelor's degree in a scientific/engineering discipline
- + years of experience in clinical diagnostics, CDx development, or regulated bioanalysis within pharma, biotech, or IVD settings
- Hands-on expertise in IHC
Preferred Qualifications
- Advanced degree (M.S./Ph.D./MBA)
- Additional experience in NGS, PCR, and flow cytometry
- Familiarity with CRO/vendor management, ligand-binding immunoassays, and translational bioanalysis
- PMP certification or equivalent training
Skills Required
- 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
Benefits & Perks
- 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
- Summer hours flexibility
Locations
- Princeton NJ, United States
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong knowledge of FDA 21 CFR Part 820 (QMSR), Part 11, CLIA, CAP, IVDR, ISO13485, and ICH-GCPintermediate
- Expertise in Design Verification, Validation, Product Risk Management, and Traceability Matricesintermediate
- Skilled in IHC assay transfer, validation, and operational readiness for clinical studiesintermediate
- Experience in instrument qualification (IQ/OQ/PQ), capacity analysis, and lab planningintermediate
- Excellent project management, cross-functional alignment, and vendor negotiation skillsintermediate
- Proficiency in QMS, EDMS, ELN, LIMS, and project management toolsintermediate
Required Qualifications
- Bachelor's degree in a scientific/engineering discipline (experience)
- + years of experience in clinical diagnostics, CDx development, or regulated bioanalysis within pharma, biotech, or IVD settings (experience)
- Hands-on expertise in IHC (experience)
Preferred Qualifications
- Advanced degree (M.S./Ph.D./MBA) (experience)
- Additional experience in NGS, PCR, and flow cytometry (experience)
- Familiarity with CRO/vendor management, ligand-binding immunoassays, and translational bioanalysis (experience)
- PMP certification or equivalent training (experience)
Responsibilities
- Serve as the primary operational lead for IHC-based CDx programs
- Ensure robustness and compliance across assay design, validation, and transfer
- Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry
- 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
- Manage IHC-focused assay development timelines, data/sample logistics, and troubleshooting
- 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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Manager II, Lab Planning & Operations, Immunohistochemistry and Development Diagnostic @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs