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Experienced Scientist, Biotherapeutics RD

Johnson & Johnson · Spring House, PA

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Role summary

Johnson & Johnson seeks an experienced scientist to lead manufacturing operations for autologous CAR-T cell therapy products in clinical trials. The role requires expertise in cGMP biotherapeutics production, regulatory compliance, and team leadership within a controlled manufacturing environment.

What they're looking for

  • Bachelor's degree minimum
  • 5+ years CAR-T or cell/gene therapy GMP manufacturing experience
  • Leadership experience directing manufacturing operations teams
  • Knowledge of cGMP regulations, FDA guidance, and ATMPs
  • Aseptic processing simulation and training experience
  • Strong problem-solving and communication abilities
  • Microsoft Office proficiency

What you'll be doing

  • Lead clinical CAR-T product manufacturing operations in cGMP environment
  • Author SOPs and technical documentation; review batch records for accuracy
  • Coordinate troubleshooting of manufacturing and equipment issues with production staff
  • Conduct training for new operations staff and serve as subject matter expert in audits
  • Drive process improvements in safety, quality, compliance, and regulatory adherence

Privacy & handoff

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What RoleLantern checked

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RoleLantern checkedNeeds clarity
Date posted2 days ago
Last source check1 day ago
Salary listedNeeds clarity
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