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:

• Own and lead consistent process validation and continuous process verification global strategy, procedures and tools for drug product manufacturing processes of sterile liquid (vial/PFS) as well as lyophilized dosage forms; this includes also qualification and validation strategy for sterilization processes e.g. steam / heat sterilization of equipment and starting materials

• Lead establishment of global standards for drug product manufacturing process control strategy, support global MSAT initiatives including writing of global SOPs and technical standards related to process validation of aseptic manufacturing DP

• Support products throughout the 3 phases of process validation (process design, process performance qualification and continuous process verification)

• Work closely with process development in support to process design stage and scale up activities securing readiness to process validation

• Develop and apply risk-based strategies for product specific process validation through product life cycle; provide guidance and oversight to Tech Transfer and local MSAT teams in the elaboration of process validation master plan, at-scale process validation as well as CPV/OPV strategy of customer products

• Review and approve process validation documentation; conduct statistical analysis on production data

• Create and review relevant sections of regulatory dossier or other communications to heath authority

• Active participation in health authority inspections as SME

• 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 equivalent experience

• Proven extensive experience and technical knowledge of equipment qualification related to aseptic drug product manufacturing processes

• Proven Extensive experience 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; experience with SAA JMP / STATISTICA software is highly desirable

• Proficient in 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.