QC Analyst I/II (Cell Therapy)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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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