Lentivirus Manufacturing Operator Be part of the manufacturing operations team responsible for production of Lentivirus vector for the autologous CAR-T products in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. Duties / Responsibilities Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise format according to Good Documentation Practices (GDP). Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements. Execute production activities common to cell culture in shake flasks and wave bioreactor, cell counting methods (i.e. Vi-Cell), thawing, passaging, aseptic technique/processing, chromatography columns or filtration(TFF, DF), filter integrity test, GE AKTA systems and/or microfiltration/ultrafiltration systems, purification, automated filler (i.e.FP50) and sterile filling using appropriate techniques. Perform tasks related to single use bioreactor operations including bioreactor setup, sampling and monitoring, and disassembly. Work in a team based, cross-functional environment to complete production tasks required by shift schedule. Aid in the development of manufacturing processes including appropriate documentation. Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members. Handle virus and human derived materials in containment areas. Qualifications / Requirements: A High School diploma with a 1-2 years of related work experience OR An Associate's or Bachelor's degree in a related field (i.e. Chemical Engineering, Biological Sciences, Chemistry or Biochemistry) is required. Experience in manufacturing, maintenance, quality, testing, or engineering areas is preferred. Knowledge of current Good Manufacturing Practices (cGMP) is preferred. Experience in the Pharmaceuticals or Biopharmaceuticals industry is preferred. Experience in an aseptic and manufacturing environment is preferred. Proficiency in English (verbal and written), as well as, good communication skills are required. Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required. Basic proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required. Availability to work in a day shift is required. Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required. This position will be based in Raritan, NJ and requires up to ten percent (10%) of domestic travel. Johnson for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave 80 hours in a 52-week rolling period 10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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