Manager II, Lab Planning & Operations

Job description

**Working with Us**
Challenging.

Meaningful.

Life-changing.

Those aren't words that are usually associated with a job.

But working at Bristol Myers Squibb is anything but usual.

Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.

Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Read more: careers.bms.com/working-with-us .

**Manager II, Lab Planning & Operations**

**Department** : Precision Medicine, Bioanalysis & Translational Sciences (PMBATS)

**Location** : Lawrenceville, NJ

**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 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

+ 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.

#LI-HYBRID

If you come across a role that intrigues you but doesn't 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.

**Compensation Overview:**

Princeton - NJ - US: $123,670 - $149,855

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 employee's 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 https://careers.bms.com/life-at-bms/.

Benefit 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 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.

**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

**On-site Protocol**

BMS has an occupancy structure that determines where an employee is required to conduct their work.

This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility.

Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com .

Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1595584
**Updated:** 2025-10-23 05:58:28.025 UTC
**Location:** Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Required Skill Profession

Other General