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7 дней назад

QC Analyst I/II (Cell Therapy)

68 045 - 89 308$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
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
QC Analyst I/II (Cell Therapy) (Quality Control/Cell Therapy): Performing QC testing for autologous CAR-T products in controlled cGMP cleanrooms with an accent on analytical sample testing, laboratory data review, and compliant documentation. Focus on executing aseptic testing, using LIMS, supporting CAR-T manufacturing, and managing work across shifts, overtime, and regulated biological-material environments.

Location: Onsite in Raritan, New Jersey, United States. The role includes routine evening and weekend shifts, unplanned overtime, and up to 5% domestic or international travel, including occasional travel to partner sites in New Jersey or Pennsylvania.

Base pay: $68,045–$89,308 per year. Performance-based bonus and/or equity may be available for eligible employees.

Company

hirify.global is a commercial-stage biotechnology company developing cell therapy platforms, including CAR-T, CAR-NK, CAR-γδ T, and non-gene-editing CAR technologies.

What you will do

  • Perform QC testing for autologous CAR-T products used in clinical trials and commercial operations.
  • Conduct analytical testing of raw material, utility, in-process, and final product samples.
  • Complete testing in compliance with procedures, standards, GMP regulations, and quality systems.
  • Perform peer review and approval of laboratory data using LIMS for testing execution and documentation.
  • Create, review, and approve QC documents, standard operating procedures, and work instructions.
  • Collaborate with Quality Assurance, Manufacturing Operations, and Analytical/Process Development while handling biological materials and hazardous chemicals.

Requirements

  • Bachelor’s degree in science, engineering, or an equivalent technical discipline.
  • At least one year of relevant work experience; biological or pharmaceutical industry experience is preferred.
  • Knowledge of Good Tissue Practices is required.
  • Strong written and oral communication skills, organization, teamwork, and the ability to interact with regulatory inspectors.
  • Ability to work routine evening and weekend shifts and accommodate unplanned overtime, including nights and weekends.
  • Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Nice to have

  • Quality Control experience.
  • Experience processing samples in biosafety cabinets using aseptic technique.
  • Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.
  • Knowledge of CAR-T QC test methods and related equipment.

Culture & Benefits

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

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