Sobre este puesto de Manager, Sample Management Operations en Legend Biotech US
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of 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.
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
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.
