7 дней назад
QC Analyst I/II (Cell Therapy)
68 045 - 89 308$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Analyst I/II (Cell Therapy) (CAR-T/cGMP): Conducting quality control testing for autologous CAR-T products in controlled cGMP cleanroom laboratories with an accent on analytical testing, aseptic sample processing, and GMP-compliant documentation. Focus on reviewing laboratory data, operating LIMS, supporting regulatory compliance, and handling biological materials and hazardous chemicals during shift-based manufacturing operations.
Location: Raritan, New Jersey, United States; onsite work with routine evening and weekend shifts, unplanned overtime, and up to 5% domestic or international travel.
Salary: $68,045–$89,308 USD base pay annually, plus performance-based bonus and/or equity for eligible roles.
Company
is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based treatments for serious diseases.
What you will do
- Perform QC testing for autologous CAR-T products supporting clinical trials and commercial manufacturing.
- Conduct analytical testing of raw materials, utilities, in-process samples, and final products.
- Complete testing in controlled cGMP cleanroom and laboratory environments.
- Perform peer review and approval of laboratory data using LIMS for execution and documentation.
- Create, review, and approve QC documents, SOPs, and work instructions.
- Collaborate with Quality Assurance, Manufacturing Operations, and Analytical/Process Development teams.
Requirements
- Bachelor’s degree in science, engineering, or an equivalent technical discipline.
- At least one year of relevant work experience, preferably in the biological or pharmaceutical industry.
- Knowledge of Good Tissue Practices; experience in a Quality Control setting is preferred.
- Experience processing samples in biosafety cabinets using aseptic technique is strongly preferred.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based products is strongly preferred; CAR-T QC test methods and equipment knowledge is a plus.
- Must be authorized to work in the United States; employment eligibility will be verified through Form I-9 and E-Verify.
Culture & Benefits
- Collaborative environment with cross-functional quality, manufacturing, and development partners.
- Medical, dental, and vision insurance and a 401(k) plan with a company match fully vested from 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, commuter benefits, family-care resources, and well-being programs.
- Benefits are available exclusively to permanent full-time employees; contractors are not eligible.
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