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5 дней назад

Sr. Manager Clinical Supply Operations (Cell and Gene Therapy)

146 410 - 192 164$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr. Manager Clinical Supply Operations (Cell and Gene Therapy): Coordinating global clinical supply operations for early clinical cell and gene therapy programs with an accent on forecasting, packaging and labeling, distribution, inventory control, and vendor management. Focus on maintaining compliant, inspection-ready supply records, managing temperature excursions and expiry risks, and ensuring continuous investigational product availability across studies.

Location: Somerset, New Jersey, United States; onsite. Applicants must be authorized to work in the United States.

Base pay: $146,410–$192,164 per year, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a biotechnology company developing cell and gene therapies, including CAR-T, TCR-T, and natural killer cell-based therapies.

What you will do

  • Coordinate clinical supply activities across global studies, countries, clinical sites, depots, CROs, and external vendors.
  • Develop demand forecasts, supply plans, resupply parameters, inventory targets, and risk-mitigation actions.
  • Coordinate packaging, labeling, distribution, returns, reconciliation, destruction, QA/QP release, and shipment documentation.
  • Manage temperature excursions, expiry risks, product disposition follow-up, deviations, investigations, CAPAs, and change controls.
  • Maintain inspection-ready clinical supply plans, pharmacy manuals, distribution instructions, eTMF records, and other study documentation.
  • Lead vendor coordination, operational meetings, issue escalation, status reporting, and continuous process improvement.

Requirements

  • Bachelor’s degree in supply chain, life sciences, pharmacy, business, or a related discipline.
  • 6+ years of experience in clinical supply operations, clinical drug supply, pharmaceutical supply chain, or related GMP operations.
  • Hands-on experience with clinical supply planning, forecasting, packaging and labeling, distribution, inventory management, reconciliation, returns, and destruction.
  • Experience supporting global clinical trials and coordinating clinical sites, depots, CROs, packaging providers, logistics partners, and vendors.
  • Experience with IRT and clinical supply or inventory systems; familiarity with CTMS, eTMF, ERP, vendor portals, and reporting tools is preferred.
  • Working knowledge of GMP, QA/QP release, temperature excursions, expiry management, inspection readiness, and clinical trial documentation.

Nice to have

  • Advanced degree or clinical supply certification.
  • Experience with oncology, biologics, cell and gene therapy, or complex temperature-controlled products.

Culture & Benefits

  • Permanent full-time employment with medical, dental, and vision insurance.
  • 401(k) retirement plan with company match fully vested on day one.
  • Eight weeks of paid parental leave after three months of employment.
  • Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
  • Additional voluntary benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family-care resources.

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