Process Expert, Aseptic Drug Products (adp) Process Support

Novartis

Durham, NC, US
$126,000 - $234,000 py; performance-based cash inc...
Onsite
Aseptic drug products manufacturing
Technology transfer and qualification
Process optimization and compliance
Novartis is seeking a Process Expert for their Aseptic Drug Products Process Support team in Durham, NC. The role involves providing frontline support in drug manufacturing processes, ensuring compliance with industry standards, and optimizing operations

Job Summary

  • This role provides front-line expert support for all process-specific issues in manufacturing, ensuring timely execution, continuous quality improvement, and compliance with cGMPs.
  • Key responsibilities include authoring and revising manufacturing documents, performing first-line evaluation of product and process issues, and supporting regulatory inspections.
  • The position offers a competitive salary range, performance-based cash incentives, eligibility for equity awards, and a comprehensive benefits package including health, retirement, and generous time off.

Matching Summary

Match Score: 85

Novartis is seeking a Process Expert for their Aseptic Drug Products Process Support team in Durham, NC. The role involves providing frontline support in drug manufacturing processes, ensuring compliance with industry standards, and optimizing operations.

Salary

$126,000 - $234,000 per year; Performance-based cash incentive and potential equity awards; Comprehensive benefits package including health, life, disability, 401(k) with match, and generous time off

Skills & Requirements

Must-have

  • Aseptic Drug Products manufacturing
  • Technology transfer and qualification
  • Process optimization and compliance
  • cGMP, SOPs, and guidelines
  • Deviation and complaint investigation
  • Root cause analysis and risk assessment

Nice-to-have

  • Continuous improvement initiatives
  • Regulatory inspection readiness
  • Cross-functional collaboration
  • Driving process technology innovations

Key Requirements

  • B.S. degree in Engineering or Life Sciences
  • 7 years of biopharmaceutical GMP manufacturing experience
  • Experience developing manufacturing documentation
  • Experience investigating manufacturing deviations
  • In-depth knowledge of FDA regulations and GMP systems
  • Applied knowledge of QbD, Six Sigma, and OE tools
  • Excellent oral and written communication skills
  • Strong technical writing ability
  • Travel up to ~20%

Work Rights

Not specified

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