Lentivirus Manufacturing Operator

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +1

Operates lentivirus manufacturing processes in a cGMP cleanroom environment, performing unit operations, recording data, and ensuring safety and quality standards are met. Requires experience in cell culture, aseptic technique, and purification methods.

What you'd actually do

  1. 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).
  2. Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
  3. 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.
  4. Perform tasks related to single use bioreactor operations including bioreactor setup, sampling and monitoring, and disassembly.
  5. Work in a team based, cross-functional environment to complete production tasks required by shift schedule.

Skills

Required

  • High School diploma with 1-2 years of related work experience OR Associate's or Bachelor's degree in a related field
  • Proficiency in English (verbal and written)
  • Good communication skills
  • Ability to lift a minimum of 25 lbs.
  • Ability to stand for a long period of time
  • Basic proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook)
  • Availability to work in a day shift
  • Ability to accommodate changes in the schedule including working in other shifts as per operational needs

Nice to have

  • Experience in manufacturing, maintenance, quality, testing, or engineering areas
  • Knowledge of current Good Manufacturing Practices (cGMP)
  • Experience in the Pharmaceuticals or Biopharmaceuticals industry
  • Experience in an aseptic and manufacturing environment

What the JD emphasized

  • cGMP
  • aseptic technique
  • Good Documentation Practices (GDP)