This position is located in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
For our successful and growing Drug Product focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the Global MSAT DP Qualification & Validation Lead position.
What you will get:
An agile career and a dynamic work culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Stein:
What you will do:
Lead global process control strategy for drug product manufacturing
Own global strategies for equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV)
Define and govern global SOPs, standards, templates, and tools aligned with regulations and best practice
Own qualification strategy for key unit operations: thawing, compounding, filling, lyophilization, and crimping
Guide Tech 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
Act as subject matter expert during health authority inspections on validation and CPV/OPV
What we are looking for:
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
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
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