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6 дней назад

Project Specialist I, Manufacturing (Cell Therapy)

90 000 - 120 000$
Формат работы
onsite
Тип работы
fulltime
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
Project Specialist I, Manufacturing (Cell Therapy): Supporting technical documentation, quality records, manufacturing scheduling, resource planning, and training coordination in a GMP manufacturing environment with an accent on batch production readiness, workforce allocation, and compliance. Focus on maintaining short-term schedules, resolving resource conflicts, coordinating technician qualifications, and improving operational reporting for cell and gene therapy manufacturing.

Location: Waltham, Massachusetts, United States. Onsite manufacturing role with cleanroom and physical environment requirements.

Salary: $90,000–$120,000 per year.

Company

hirify.global is a technology-driven biotechnology company providing integrated technologies, services, and manufacturing expertise for advanced therapies.

What you will do

  • Support manufacturing technical documentation and quality records, including deviations, CAPAs, change controls, SOPs, and batch records.
  • Develop and maintain short-term manufacturing schedules, technician assignments, and resource plans across production teams.
  • Coordinate onboarding, training matrices, qualification tracking, requalification, and continuing education for manufacturing technicians.
  • Track scheduling adherence, resource utilization, training completion, and workforce planning metrics.
  • Coordinate schedule updates and resource changes with manufacturing supervisors, supply chain planning, and other stakeholders.
  • Support operational excellence initiatives and identify improvements to scheduling, training workflows, and cross-team communication.

Requirements

  • Bachelor’s degree with at least 3 years of related experience, or a master’s degree with at least 1 year of related experience.
  • Experience in manufacturing, technical operations, or a GMP environment.
  • Experience with manufacturing scheduling, resource planning, or workforce coordination.
  • Proficiency in Microsoft Office, especially Excel, for scheduling, tracking, and reporting.
  • Familiarity with systems such as SAP, electronic batch records, or Veeva.
  • Ability to stand, walk, bend, stretch, lift 25–50 pounds, and work with PPE in a cleanroom environment.

Nice to have

  • Experience with autologous gene or cell therapy.
  • Experience in contract manufacturing or a client service organization.

Culture & Benefits

  • Fast-paced GMP manufacturing environment.
  • Collaborative work with manufacturing, supply chain planning, and cross-functional project teams.
  • Regular and full-time employment.

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