Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Full-timeOn-siteSenior
Stein (AR)
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CHCH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Stein (AR)
Full-timeOn-siteSenior
Data Science
Nejo AI Summary
Defining global qualification strategies for aseptic drug product manufacturing, covering thawing, compounding, filling, and lyophilization processes. Expertise in process validation for sterile biologics, including lyophilized formats, required. Relocation assistance available.
Requirements
- Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field, or equivalent experience
- Expertise in equipment qualification for aseptic drug product manufacturing
- Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats
- Proven experience with regulatory submissions and pre‑approval inspections
- Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred
- Knowledge of risk assessment, deviation management, change control, and root cause analysis
- Excellent English communication, documentation, leadership, and cross‑functional collaboration skills
Tasks
- Lead global process control strategy for drug product manufacturing
- Own global strategies for equipment qualification, process validation, and continued process verification
- Define and govern global SOPs, standards, templates, and tools aligned with regulations
- Own qualification strategy for thawing, compounding, filling, lyophilization, and crimping
- Guide Tech Transfer and local MSAT teams on validation strategies and sampling plans
- Review and approve validation documentation
- Analyze production data using appropriate statistical methods
- Act as subject-matter expert during health authority inspections
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Compensation programs that recognize high performance
Corporate Discounts
- Numerous lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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CHCH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Stein (AR)
Full-timeOn-siteSenior
Data Science
Nejo AI Summary
Defining global qualification strategies for aseptic drug product manufacturing, covering thawing, compounding, filling, and lyophilization processes. Expertise in process validation for sterile biologics, including lyophilized formats, required. Relocation assistance available.
Requirements
- Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field, or equivalent experience
- Expertise in equipment qualification for aseptic drug product manufacturing
- Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats
- Proven experience with regulatory submissions and pre‑approval inspections
- Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred
- Knowledge of risk assessment, deviation management, change control, and root cause analysis
- Excellent English communication, documentation, leadership, and cross‑functional collaboration skills
Tasks
- Lead global process control strategy for drug product manufacturing
- Own global strategies for equipment qualification, process validation, and continued process verification
- Define and govern global SOPs, standards, templates, and tools aligned with regulations
- Own qualification strategy for thawing, compounding, filling, lyophilization, and crimping
- Guide Tech Transfer and local MSAT teams on validation strategies and sampling plans
- Review and approve validation documentation
- Analyze production data using appropriate statistical methods
- Act as subject-matter expert during health authority inspections
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Benefits
Bonuses & Incentives
- Compensation programs that recognize high performance
Corporate Discounts
- Numerous lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CH12 Lonza AG
Industry
Pharmaceuticals
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Not a perfect match?
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