\\n Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there\\xe2\\x80\\x99s 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\\xe2\\x80\\x99s 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 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 and join us by applying for this senior position as Global DP Sterility Assurance and Cleaning Validation Lead. Become part of this exciting opportunity and apply now!

Key Responsibilities:

• Responsible MSAT Lead for contamination and cross-contamination control strategy for sterile DP manufacturing
• Define and lead the global cleaning concept of process equipment, clean rooms and systems related to DP aseptic manufacturing of liquid and lyophilized drug products of a variety of different molecule types e.g. small and large molecules, highly potent drugs / ADC as well as BSL-2
• Specifically, develop product decontamination methods and procedures, cleaning methods and procedures including corresponding effectiveness assessment
• Define global procedures and standards for cleaning concept, validation strategy, creation of cleaning validation master plan, cleaning monitoring program, cleaning verification changeover program for fully automated, multi-product biologics aseptic manufacturing facilities
• Support global standards and procedures related to environmental monitoring programs, microbial decontamination cycle development and validation, sterilization processes and validation and all related processes securing sterility assurance
• Ensure cleaning methods and practices adhere to current industry best practice, GMP and regulatory requirements; lead process improvement projects pertaining to cleaning validation activities
• Provide support to cross functional technical transfers as well as operational teams at local sites for new product introduction evaluation including support to contamination and cross contamination risk assessments
• Support customer calls and GMP audits
• Support local sites to regulatory inspection readiness providing guidance and oversight to ensure cleaning strategy, validation and verification changeover are well understood, implemented and represented to regulators.
• Support deviation management and root cause investigation and corresponding CAPAs related to cleaning of equipment and systems for DP aseptic manufacturing

Key Requirements:

• Ph.D. or Master in pharmaceutical technology sciences, microbiology, pharmaceutical engineering, biochemistry, or related fields or similar qualification
• Extensive experience in biotech / pharma industry and in deep knowledge of sterility assurance and cleaning methods as well as aseptic drug product manufacturing experience is required
• In depth knowledge of risk assessments related to contamination and cross contamination prevention
• Previous working experience with BSL-2 and ADC products is an asset
• Strong knowledge of GMP and regulatory validation requirements
• Excellent writing skills and excellent communication skills with command of English, 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\\xe2\\x80\\x99s 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.\\n \\n \\n \\n \\n \\n

\\n \\n eQuest\\n \\n

\\n