Manager II, Lab Planning & Operations at Bristol-Myers Squibb

Princeton, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Leadership and operational oversight experience in companion diagnostic (CDx) assay design, development, and clinical testing in a CLIA-certified environment
Expertise in immunohistochemistry (IHC) as the primary technology platform
Background in NGS, PCR/molecular diagnostics, and flow cytometry
Knowledge of compliance standards including FDA 21 CFR Part 820, IVDR, CLIA, CAP, ISO13485, and ICH-GCP
Experience with Design Verification, Validation, Product Risk Management, and Traceability Matrix execution
Expertise in instrument qualification (IQ/OQ/PQ), capacity planning, and LIMS, ELN, and clinical data management systems
Experience managing CRO, central lab, and diagnostic vendor partnerships
Ability to drive timelines, data/sample logistics, troubleshooting, risk identification, mitigations, and CAPA implementation
Knowledge of Quality Management Systems including FDA 21 CFR Part 820 (Design Control), Part 11, IVDR, ICH-GCP, and GLP
Experience supporting internal/external audits and regulatory submissions (CDx, LDT, IVDR filings)
Strong cross-functional collaboration skills with scientific, regulatory, QA, clinical, IT, finance, and legal teams
Financial and resource planning skills, including budgets, staffing, and forecasting for CLIA/CDx operations

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

Skills

Key technologies and capabilities for this role

IHCNGSPCRFlow CytometryCLIACAPISO13485ICH-GCPFDA 21 CFR Part 820IVDRDesign VerificationDesign ValidationProduct Risk ManagementTraceability MatrixAssay Development

Questions & Answers

Common questions about this position

What is the location for this Manager II, Lab Planning & Operations role?

The position is located in Lawrenceville, NJ.

What are the key technical skills required for this position?

The role requires leadership in immunohistochemistry (IHC) as the primary platform, with valuable experience in NGS, PCR/molecular diagnostics, and flow cytometry. Expertise in regulatory standards like FDA 21 CFR Part 820, IVDR, CLIA, CAP, ISO13485, and ICH-GCP is essential, along with skills in LIMS, ELN, instrument qualification (IQ/OQ/PQ), and assay lifecycle management.

What does the company culture at Bristol Myers Squibb feel like?

The culture is described as challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and a focus on work-life balance and flexibility.

What benefits does Bristol Myers Squibb offer?

The company offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

What makes a strong candidate for this lab operations manager role?

Strong candidates will have operational leadership experience in CDx assay design, development, and validation in a CLIA-certified environment, with expertise in IHC and complementary diagnostics, regulatory compliance, and project/CRO management.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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