Operator II, Drug Substance

Novo Nordisk•Bloomington, IN

About The Position

The Operator II, Drug Substance executes drug substance manufacturing operations with a high degree of independence. The role performs process steps, monitors equipment, and troubleshoots routine issues while complying with GMP, safety, and quality requirements to ensure reliable production of high-quality product. This is a mid-level position on the Upstream Manufacturing team and provides training and skill development for work in a cGMP biomanufacturing environment. The Manufacturing Operator produces biopharmaceutical products through the production of genetically modified mammalian cells. The work uses general analytical and liquid-handling equipment, cellular diagnostic machinery, biosafety cabinets, aseptic techniques, pumps, tube fusers, and tube sealers. The role performs small- and large-scale cell culture work in a clean-room environment under direct supervision and safely operates and cleans applicable processing equipment. The role works nights from 6:00 PM to 6:30 AM on a rotating 3-2-2 schedule. Working conditions are heating, ventilation, and air-conditioning controlled, and the employee must be able to work in a clean-room environment as needed.

Requirements

  • Bachelor's degree in a related field from an accredited university and zero years of relevant experience; alternatively, an associate's degree in a related field from an accredited college or university and zero years of relevant experience; or a high school diploma or equivalent and at least one year of relevant experience.
  • Ability to work in a clean-room environment as needed.
  • Ability to frequently lift or move up to 20 pounds and occasionally lift or move up to 50 pounds.

Responsibilities

  • Perform drug substance manufacturing process steps, monitor equipment, and troubleshoot routine issues in compliance with GMP, safety, and quality requirements.
  • Manufacture biopharmaceutical products through production of genetically modified mammalian cells.
  • Perform small- and large-scale cell culture work in a clean-room environment under direct supervision.
  • Manipulate cell cultures in shake flasks and single-use bioreactors (SUBs).
  • Analyze cell cultures using automated cell counters, bioanalyzers, sample preparation, osmometers, and other applicable laboratory instrumentation.
  • Use basic biomanufacturing equipment, including tube fusers, tube sealers, pumps, scales, and balances.
  • Clean and sterilize applicable processing equipment using CIP/SIP.
  • Operate equipment safely within the assigned area.
  • Perform other duties as assigned.
  • Comply with EHS responsibilities for the position.

Benefits

  • Leading pay and annual performance bonus for all positions.
  • Generous paid time off, including 14 paid holidays.
  • Health, dental, and vision insurance effective day one.
  • Guaranteed 8% 401(k) contribution plus an individual company match option.
  • Family-focused benefits, including 14 weeks of paid parental leave and 6 weeks of paid family medical leave.
  • Free access to Novo Nordisk-marketed pharmaceutical products.
  • Tuition assistance.
  • Life and disability insurance.
  • Employee referral awards.
  • Opportunities, resources, and mentorship to support career growth.
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