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20 часов назад

Operations Supervisor (CAR-T)

96 267 - 126 351$
Формат работы
onsite
Тип работы
fulltime
Грейд
lead
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
Operations Supervisor (CAR-T): Directing daily production of personalized CAR-T cell therapies in a sterile cGMP environment with an accent on compliant manufacturing, shift leadership, and cross-functional execution. Focus on supervising CAR-T process operations, supporting investigations and change controls, and driving manufacturing improvements under FDA and cleanroom requirements.

Location: Onsite in Raritan, New Jersey, United States. Availability for first- or second-shift work, evenings, weekends, and unplanned overtime is required.

Salary: $96,267–$126,351 USD per year, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based treatments for life-threatening diseases.

What you will do

  • Lead and supervise component preparation, manufacturing support, mock cell, and CAR-T process operations according to SOPs, batch records, and cGMP requirements.
  • Run shift-start and production wrap-up meetings, assign daily tasks, and guide operators on the production floor.
  • Perform production activities when needed while maintaining safety, quality, and cGMP compliance.
  • Support manufacturing investigations, procedures, work instructions, master batch records, forms, and change controls.
  • Partner with Manufacturing, Engineering, Quality, and external stakeholders to resolve production issues and execute projects.
  • Support personnel development, process development, continuous improvement, and operational efficiency initiatives.

Requirements

  • Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.
  • At least six years of operations experience in a cGMP biotech or biopharma environment, with prior manufacturing, quality, or engineering experience.
  • Knowledge of cGMP regulations, FDA guidance for cell-based products, and cleanroom behaviors.
  • Strong leadership, communication, organizational, analytical, problem-solving, and critical-thinking skills.
  • Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook, with the ability to manage multiple priorities in a matrixed environment.
  • Ability to handle biological materials and hazardous chemicals, lift at least 25 pounds, stand for extended periods, and meet stated vision, hearing, and dexterity requirements.

Nice to have

  • Experience with Operational Excellence and/or Lean Manufacturing.

Culture & Benefits

  • Permanent full-time employees receive 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 benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, family-care resources, and well-being programs.

Hiring process

  • Selected applicants must complete Form I-9 employment verification through E-Verify.

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