This position is located in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
For Drug Product Services (DPS) , our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Stein and Basel, Switzerland we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment! Join this outstanding team by applying for this senior position as Global MSAT Drug Product Qualification and Validation Lead!
What you'll get:
An agile career and a dynamic work culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
What you'll do:
Serve as global process owner for DP manufacturing process control strategy including equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV) for liquid (vial/PFS/Cartridges) as well as lyophilized dosage forms for biological products.
Lead the development and governance of corresponding global SOPs, Standards, Templates, and Tools aligned with regulatory and industry best practices.
Own the equipment qualification (PQ) strategy for key unit operations e.g. DS thawing, compounding, filling, lyophilization, and crimping.
Support customer products throughout the 3 phases of process validation (process design, PPQ and CPV) by providing guidance and oversight to Tech Transfer and local MSAT teams for optimum justification of product specific validation strategies (PPQ and CPV) including scale up activities and statistical support e.g. sampling plan justification.
As required, review and approve process validation documentation; conduct statistical analysis on production data for each phase of process validation.
Active participation in health authority inspections as SME for process validation and CPV/OPV strategy, as applicable
Implement Process Capability/Quality/Cost Improvement Changes
Enable innovation and technical strategy projects associated to DP aseptic manufacturing
What we're looking for:
Ph.D. in pharmaceutical sciences, pharmaceutical engineering, biochemistry, or related fields or similar qualification
Proven experience and technical knowledge of equipment qualification related to aseptic drug product manufacturing processes
Extensive experience and technical knowledge of process validation and current validation approaches for sterile manufacturing of biological drug products (lyophilized products, liquid in vials and PFS) including proven experience with regulatory submission with HAs and PAI.
Profound understanding of statistics, statistical analysis in support to equipment qualification, process validation and continuous process verification. Applied Statistical Data Science certification or lean black belt certification required; experience with SAA JMP / STATISTICA software is highly desirable.
In depth knowledge of risk assessments, deviation and change management, root cause investigation analysis
Excellent writing skills and documentation practices
Excellent communication skills and command of English both written and oral
Excellent leadership and interpersonal skills; proven ability as team player and ability to manage cross-functional teams.
Excellent planning and organizing skills
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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