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LOLonza

Global MSAT Lyophilization Equipment and Process Lead(m/w/x)

Stein (AR)
Full-timeOn-siteSenior

Global strategy for freeze dryer qualification and lyophilization process transfer across a DP GMP network. Extensive experience qualifying freeze dryers for aseptic drug product processes required. Global scope with international collaboration.

Requirements

  • PhD or equivalent in pharmaceutical sciences, engineering, biochemistry, or related field
  • Extensive experience qualifying freeze dryers for aseptic drug product processes
  • Proven expertise transferring lyophilization processes across sites and scaling to commercial
  • Strong background in validation, statistics, and process control strategy for lyophilization
  • Experience with regulatory submissions, Health Authority interactions, and PAIs
  • Skilled in risk assessment, deviations, change control, and root cause analysis
  • Track record leading global projects; excellent communication and English proficiency

Tasks

  • Own the global strategy for freeze dryer qualification
  • Define and maintain global equipment comparability standards
  • Lead the global lyophilization process transferability strategy
  • Co-lead lyophilization process improvements and scale-up
  • Oversee tech transfer across the DP GMP network
  • Support regulatory submissions and act as SME during inspections
  • Drive innovation and standardization of lyophilization technologies
  • Coach teams and foster cross-site collaboration

Work Experience

  • approx. 4 - 6 years

Education

  • Doctoral / PhD

Languages

  • EnglishBusiness Fluent

Benefits

Bonuses & Incentives

  • Compensation programs that recognize high performance

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace
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