6 дней назад
MOI/QCCB Lead Operator (CAR-T)
63 000 - 96 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
MOI/QCCB Lead Operator (CAR-T): Executing MOI and QCCB manufacturing processes for autologous CAR-T products in a controlled cGMP cleanroom environment with an accent on cell culturing, purification, aseptic processing, and cryopreservation. Focus on performing batch-recorded unit operations, maintaining GMP compliance, supporting process troubleshooting, and driving continuous improvement in manufacturing operations.
Location: Raritan, New Jersey, United States of America; on-site manufacturing role, Monday–Friday, 08:00–16:30
Salary: $63,000–$96,000 annual base pay
Company
Johnson & Johnson develops healthcare, innovative medicine, and MedTech solutions, including treatments and technologies designed to improve patient outcomes.
What you will do
- Lead and independently execute Multiplicity of Infection (MOI) and Quality Control Cell Bank (QCCB) manufacturing processes for autologous CAR-T products.
- Perform cell culturing, purification, aseptic processing, cryopreservation, and other manufacturing unit operations in a controlled cGMP cleanroom.
- Execute procedures according to SOPs, batch records, and production schedules while maintaining accurate GDP-compliant documentation.
- Support manufacturing process development, routine troubleshooting, non-routine activities, investigations, audits, and schedule adjustments.
- Drive continuous improvement, ensure materials are available, and maintain a clean and safe production environment.
- Work cross-functionally, complete assigned training, and support production activities involving human-derived materials in containment areas.
Requirements
- High school diploma with 6 years of biotechnology, pharmaceutical, or equivalent industry experience.
- Bachelor’s degree in Life Sciences or Engineering with 2 years of biotechnology, pharmaceutical, or equivalent industry experience is preferred.
- Basic technical knowledge of manufacturing processes, manufacturing-support and laboratory equipment, routine and non-routine testing, and sampling methods.
- Working knowledge of cGMP requirements, process excellence tools, SOPs, batch records, and Good Documentation Practices.
- Accurate data-entry skills in manufacturing systems such as SAP and electronic batch records.
- Ability to work on site in Raritan, New Jersey, perform gowning procedures, work in hazardous or containment areas, stand and walk frequently, and lift up to 25 pounds.
Culture & Benefits
- Inclusive work environment focused on respect, diversity, dignity, and equal employment opportunity.
- Paid vacation, sick time, holidays, parental leave, caregiver leave, volunteer leave, military spouse time-off, and other leave programs subject to applicable policies.
- Opportunity to contribute to clinical and commercial manufacturing operations for CAR-T products.
- Safety-focused workplace with required personal protective equipment and procedures for manufacturing environments.
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