Lonza seeks a Global MSAT Drug Product Qualification and Validation Lead to direct process control strategies and validation activities for sterile biologics manufacturing at its Swiss sites.
This position sits within Lonza's expanding Drug Product division in Basel and Stein, Switzerland. The role focuses on directing worldwide process control strategies for drug product manufacturing, ensuring robust validation frameworks and compliance across operations.
Responsibilities
- Direct worldwide process control strategies for drug product manufacturing
- Manage global approaches for equipment qualification, process validation, and ongoing process verification
- Establish and oversee global standard operating procedures, standards, templates, and tools in line with regulations and industry best practices
- Develop qualification strategies for critical unit operations including thawing, compounding, filling, lyophilization, and crimping
- Advise Technology Transfer and local MSAT teams on validation strategies, scale-up, and sampling plans
- Review and approve validation documentation; analyze production data using appropriate statistical methods
- Serve as a subject-matter expert during health authority inspections on validation and CPV/OPV
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
- Knowledge of risk assessment, deviation management, change control, and root cause analysis
- Excellent English communication, documentation, leadership, and cross-functional collaboration skills
Nice to have
- Data Science certification or Lean Six Sigma Black Belt preferred
What the company offers
- An agile career and a dynamic work culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- Relocation assistance is available for eligible candidates and their families, if needed
- Numerous lifestyle, family, and leisure benefits
About the company
Lonza fosters a collaborative and inclusive environment grounded in core values of accountability, excellence, passion, and integrity. The company is committed to diversity and creating an ethical workplace for all employees.
- Core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together.
- We value diversity and are committed to creating an inclusive environment for all employees.
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