Quality Control Analyst, CAR-T Analytics - Days

Company: Mattson Resource Group
Location: Raritan
Posted on: May 28, 2023

Job Description:

Analyst - QC Analytics - DAY SHIFT!Direct Hire - Great Benefits - Annual Bonus and MORE!10-hour shifts between the operational hours of 8am-6pm (Wednesday - Saturday or Sunday - Wednesday), and provide occasional support on the weekends or other shiftsAre you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today!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 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 (e.g., LIMS, iLAB) for execution and documentation of testing. Build, review, and approve relevant QC documents, SOP's, and WI's. QualificationsEducation: Minimum of a Bachelor's or equivalent University Degree required; focused degree in Biology, Biochemistry, or related scientific field is preferred Experience and Skills: Required: Minimum 2 years of relevant work experience Knowledge of cGMP regulations and Good Documentation Practices (GDP) Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays 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 8am-6pm (Wednesday - Saturday or Sunday - Wednesday), and provide occasional support on the weekends or other shifts Requires the 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 Requires up to 5% domestic travel to other sites/locations The anticipated base pay range for this position is $60,000 to $96,600. PDN-99253cdd-f575-4864-ba74-60619a230b1c

Keywords: Mattson Resource Group, Trenton , Quality Control Analyst, CAR-T Analytics - Days, Professions , Raritan, New Jersey