MSAT Expert Drug Product 80 - 100% (m/f/d) Our Offering Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Our Company About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Planet Performance People Responsible Sourcing Global Quality Careers Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Contact Our Offering Corporate Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Back Our Company Corporate About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Planet Performance People Responsible Sourcing Global Quality Back Careers Corporate Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Back Contact Corporate Back MSAT Expert Drug Product 80 - 100% (m/f/d) Switzerland, Stein 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.   Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and apply for the position as MSAT Expert where you will be responsible for successful drug product and manufacturing process transfers as well as implementation at the manufacturing site. Join us to lead projects to improve and expand manufacturing capabilities across our DPS network. Key Responsibilities: Participate in GMP risk analysis for the manufacturing processes and Contamination Control Strategy of the facility Contribute to the development and implementation of standardized MSAT procedures and processes (e.g. qualification standard and strategy, single use system…) Partake in cross-functional teams as MSAT Expert tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale Support new product introduction by evaluating/developing ‘fit for purpose’ processes Take care of process monitoring and process control strategy as well as complex data analysis Own concepts on site or across the DPS network continuously improving in quality and efficiency in compliance to cGMPs, SOPs, EHS and applicable guidelines Lead Performance qualification activities for new equipment, filling line or a facility and support Process Performance Qualification of Biologics License Application projects Lead complex product and process related investigations and deviations including complaints actions and resolve technical challenges within area of expertise. Maintain processes at Inspection readiness level and to provide the necessary support in any internal or external audits as well as in Back/Front office or in facility tours Key requirements: University degree preferably in Biotechnology, Chemistry, Pharmacy, Engineering, Pharmaceutical Technology or equivalent scientific degree / equivalent experience Working experience in aseptic drug product manufacturing (clinical product and/or commercial product) Proven process and regulatory understanding in Sterile Manufacturing, cGMP and writing SOPs IT knowledge in SAP or MES is an asset Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor Experience in international inspection / audit is an asset Fluency in English, German is an asset 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. Reference: R57453 Apply Ways to Contact Contact Us Regulatory Support Locations Site Tours Partnering with Us Resources Knowledge Center Meet the Experts Upcoming Events Terms & Conditions Terms and Conditions Legal Disclaimer Privacy Policy California CCPA Notice Transparency in Coverage Lonza.com Company Overview News & Media Investor Relations Sustainability Careers © 2024 Lonza. All rights reserved. Cookie Settings