Legendcareers

Sr. Manager Clinical Supply Operations

Somerset, New Jersey, United States. Posted a month ago

The role

This person will support the execution of global patient supply activities for early clinical Cell and Gene Therapy programs. They will coordinate investigational product planning, packaging, labeling, distribution, inventory, and quality release across clinical sites, depots, CROs, and external vendors.

What you will do

  • Coordinate supply activities across multiple studies, countries, sites, depots, vendors, and systems.
  • Maintain accurate inventory visibility.
  • Manage temperature excursions, expiry risk, documentation gaps, and shipment issues.
  • Execute clinical supply plans, packaging, labeling, releases, and global distribution.
  • Develop demand forecasts, supply plans, resupply parameters, and inventory targets.
  • Coordinate packaging, labeling, distribution, returns, reconciliation, and destruction.
  • Support studies from start-up through closeout.
  • Coordinate clinical label text, translation, review, approval, and reconciliation.
  • Coordinate QA and QP release activities.
  • Manage distribution activities and shipment documentation with logistics providers and depots.

Required qualifications

  • Bachelor’s degree in supply chain, life sciences, pharmacy, business, or a related discipline; equivalent relevant experience may be considered.
  • 6+ years of progressive experience in clinical supply operations, clinical drug supply, pharmaceutical supply chain, or closely related GMP operations within a sponsor, CRO, or clinical supply service
  • Demonstrated independent ownership of multiple studies, vendors, complex workstreams, or operational improvements.
  • Hands-on experience with clinical supply planning, demand forecasting, packaging and labeling, distribution, inventory management, reconciliation, returns, and destruction.
  • Experience supporting global clinical trials and working with clinical sites, depots, CROs, packaging providers, logistics partners, and other external vendors.
  • Experience with IRT and clinical supply or inventory systems.
  • Working knowledge of GMP requirements, QA/QP release, temperature excursions, expiry management, inspection readiness, and clinical trial documentation.
  • Strong operational ownership, attention to detail, follow-through, and ability to work independently in a fast-moving environment.
  • Ability to interpret study needs, inventory data, forecasts, and system outputs.
  • Effective vendor-management skills.
  • Comfort working across multiple systems and maintaining accurate, inspection-ready documentation.
  • Strong problem-solving, risk-management, prioritization, and process-improvement skills.

Nice to have

  • Advanced degree or relevant clinical supply certification
  • Familiarity with CTMS, eTMF, vendor portals, ERP, reporting tools, or related platforms
  • Experience with oncology, biologics, cell and gene therapy, or other complex temperature-controlled products

Benefits

  • Medical, dental, and vision insurance
  • 401(k) retirement plan with a company match that vests fully on day one
  • Eight weeks of paid parental leave after three months of employment
  • Paid time off including vacation, personal, sick, floating holidays, and eleven company holidays
  • Flexible spending and health savings accounts
  • Life and AD&D insurance
  • Short- and long-term disability coverage
  • Legal assistance
  • Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
  • Voluntary commuter benefits
  • Family planning and care resources
  • Well-being initiatives and peer-to-peer recognition programs

Before you apply

  • Applicants must be authorized to work in the United States
  • Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances the next generation of cell therapy through a portfolio of innovative technologies.

Sr. Manager Clinical Supply Operations at Legendcareers | JobZoey