Manager, Sample Management Operations

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Manager, Sample Management Operations as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sample Management Operations Manager is responsible for overseeing end-to-end sample management across Legend pipeline studies. The role strengthens visibility, accountability, and coordination across sites, CROs, central labs and specialty labs.

Key Responsibilities

• Manage the operating model for sample management across current and future studies.
  
• Map and standardize workflows across sites, CROs, central labs, specialty labs, the sample management vendor, and sponsor stakeholders.
  
• Create visibility into critical handoffs, chain of custody, issue resolution, reconciliation activities, and operational dependencies.
  
• Monitor operation trends and proactively identify operational risks and mitigation plans that reduce delayed, lost, or poorly coordinated samples.
  
• Serve as lead for sample tracking and oversight capabilities enabled through the sample management vendor.
  
• Work with study teams and external vendors to reduce delays, missing data, and operational burden at sites.
  
• Support readiness for inspections, audits, and quality reviews related to sample operations.
  
• Create playbooks, templates, and role clarity to support consistent execution across studies.
  
• Capture lessons learned and apply them to future study planning and execution.
  
• Performs other duties as required.
• Works closely with Sr. Director of Clinical Operations and collaborates with Clinical Operations, Data Management, QA, ITQA, central labs, specialty labs, CROs, sites, and other cross-functional stakeholders.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience.
  
• Experience in clinical operations with exposure to sample management, lab operations, or related oversight functions required.
  
• Experience developing or improving complex operational workflows strongly preferred.
  
• Experience with central labs, specialty labs or sample tracking solutions preferred.
  
• Oncology, cell therapy, or early-phase clinical development experience preferred.
  
• Ability to travel as necessary (up to 10%).
• Effective oral, written, and interpersonal communication skills.
• Strong organizational, project management, and issue resolution skills.
  
• Ability to identify operational risk and develop practical mitigation strategies.
  
• Strong attention to detail while maintaining end-to-end process visibility.
  
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project and applicable operational tools).
  
• Working knowledge of GCP, FDA, and ICH Guidelines.

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$127,313—$167,099 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.