Sr. Process Expert

Novartis UK

Haiyan, Zhejiang Province, China
Process validation strategies
Technical transfer activities
Process knowledge ownership
Responsible for technology transfer activities at site level, including scale-up or process adaptations, leading technical transfer project teams and liaising with involved functions

Job Summary

  • Responsible for technology transfer activities at site level, including scale-up or process adaptations, leading technical transfer project teams and liaising with involved functions.
  • Owns the process knowledge of assigned products throughout the commercial lifecycle, maintaining oversight on process capability through data trending and statistical analysis to ensure robustness and continuous improvement.
  • Provides specialist knowledge and expertise as a Subject Matter Expert (SME) of specific pharmaceutical processes or technologies, overseeing standards to maintain and improve existing and implement new innovative manufacturing technologies.

Matching Summary

Responsible for technology transfer activities at site level, including scale-up or process adaptations, leading technical transfer project teams and liaising with involved functions.

Skills & Requirements

Must-have

  • Process validation strategies
  • Technical transfer activities
  • Process knowledge ownership
  • Manufacturing process technologies
  • Subject Matter Expert (SME)
  • GMP change control processes

Nice-to-have

  • Continuous improvement
  • Data trending and statistical analysis
  • Inspection readiness
  • Scientific experiment design and reporting
  • Harmonize and optimize technical processes

Key Requirements

  • cGMP knowledge
  • SOP knowledge
  • Process steps knowledge
  • Training production staff
  • Deviation investigations
  • CAPA ownership
  • Change record ownership

Work Rights

Not specified

Tailored Resume

Cover Letter