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Lonza
15d ago

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

Stein (AR)
Full-timeOn-siteSenior

Description

In this role, you will take charge of the global strategy for freeze dryer qualification and lead efforts to enhance lyophilization processes. Your work will involve overseeing tech transfers, supporting regulatory submissions, and driving innovation across the organization.

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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

Education

Doctoral / PhD

Work Experience

approx. 4 - 6 years

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

Languages

English – Business 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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