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Analyst Quality Control, Analytics
- Raritan, Illinois, United States
- Raritan, Illinois, United States
À propos
Location: Raritan, New Jersey. Shift: Wednesday – Saturday, 2pm – 12am. Role: Analyst, Quality Control Analytics for autologous CAR‑T product manufacturing. The position is within Janssen Pharmaceuticals, Inc., a member of Johnson&Johnson’s Family of Companies, and supports the development, manufacture and commercialization of CAR‑T therapy in partnership with Legend Biotech USA Inc. Key Responsibilities
Ensure testing is completed in compliance with all applicable procedures, standards and current Good Manufacturing Practices (cGMP) regulations. Conduct analytical testing of raw material, utility, in‑process or final product samples submitted to the QC laboratories. Collaborate with Process Development, Quality and Operations to transfer process/analytical testing to cGMP facility for product manufacturing. Perform peer review and approval of laboratory data. Use electronic systems (LIMS, iLAB) for execution and documentation of testing. Build, review and approve relevant QC documents, SOPs and work instructions. Qualifications
Education: Bachelor’s degree (or equivalent) in Biology, Biochemistry, Microbiology or related scientific field. Required experience: Minimum 2years of relevant work experience in a quality control setting. Knowledge of cGMP and Good Documentation Practices (GDP). Experience performing cellular and/or molecular techniques such as qPCR, ELISA, cell culture or potency assays. Experience with manual sample processing. Excellent written and verbal communication skills. Preferred: Experience within the biopharmaceutical/gene therapy or biologics industry, familiarity with LIMS/SAP or equivalent systems. Additional Requirements
Ability and flexibility to work a second shift of 10hours (2pm–12am, Wednesday–Saturday). Capacity to meet physical demands: lift up to 20lbs, stand or sit for extended periods, perform visual inspections of materials. Up to 5% domestic travel to other sites. Compensation & Benefits
Base pay range: $61,000–$110,000USD. Eligible for the Company’s consolidated retirement plan (401(k)) and savings plan. Paid time off: vacation (up to 120hrs/cycle), sick leave, holiday pay (13days), personal and family time (up to 40hrs), parental leave (480hrs), bereavement leave, caregiver leave, volunteer leave, and military spouse time‑off. Equal Opportunity Employer
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. The company commits to providing an inclusive interview process and accommodations for applicants with disabilities. For accommodations, external applicants can contacthttps://www.jnj.com/contact-us/careers; internal employees may contact AskGS for resources.
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Compétences linguistiques
- English
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