Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T! This position will be located in Raritan, NJ!
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Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!
The Quality Control Analyst is responsible for completing QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Key Responsibilities: Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products. Perform peer review/approval of laboratory data. Use electronic systems (LIMS, iLAB) for execution and documentation of testing. Build, review, and approve relevant QC documents, SOPs, and WIs. Education: Minimum of a Bachelor's or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, or related scientific field is preferred Experience and Skills: Required: Minimum 2 years of relevant work experience Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, ELISA, Cell Culture, and/or Potency assays Experience with Manual Sample Processing Excellent written and verbal communication skills Preferred: Experience in a Quality Control setting Experience within Biopharmaceutical or Pharmaceutical industry Work experience in Cell and/or Gene Therapy or Biologics Experience with LIMs and SAP or equivalent systems Other: Requires ability and flexibility to work 10-hour shifts between the operational hours of 8 am - 6 pm, Sunday - Wednesday, or Wednesday - Saturday, and provide occasional support for other shifts Requiresthe ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing This position may require up to 10% of domestic and international travel The salary for this position is anticipated to be between $62,000 and $95,000 Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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#CAR-T
