Process Expert, Aseptic Drug Products (adp) Process Support

Novartis UK

Durham, NC, US
Base: $108,500.00 - $201,500.00; bonus/equity: per...
Onsite
Aseptic drug products manufacturing
Gmp systems and fda regulations
Process optimization and innovation
This position will support critical project lifecycles from technology transfer and qualification of new processes, leading into commercial operations

Job Summary

  • This position will support critical project lifecycles from technology transfer and qualification of new processes, leading into commercial operations.
  • The Process Expert will play a key role in ensuring seamless integration of new technologies, process optimization, and compliance into various ADP process workstreams.
  • US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.

Matching Summary

This position will support critical project lifecycles from technology transfer and qualification of new processes, leading into commercial operations.

Salary

Base: $108,500.00 - $201,500.00; Bonus/Equity: performance-based cash incentive and annual equity awards; Benefits: comprehensive benefits package including health, life, disability, 401(k), generous time off

Skills & Requirements

Must-have

  • Aseptic Drug Products manufacturing
  • GMP systems and FDA regulations
  • Process optimization and innovation
  • Manufacturing documentation review
  • Deviation and CAPA investigation

Nice-to-have

  • Quality by Design principles
  • Operational excellence tools
  • Cross-functional collaboration
  • Resilience and risk management

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

Work Rights

Not specified

Tailored Resume

Cover Letter