Technology Transfer Lead 80-100%
vor 3 Wochen
Today, Lonza is a global leader in life sciences operating across five 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 Basel, Switzerland, we have an outstanding opportunity as Technology Transfer Lead. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment Are you ready for your next challenge? Apply now
Key responsibilities:
Manage technical activities for drug product transfers from clinical development to first commercial launch of assigned projects
Define and monitor project scope, timing and progress
Lead setup, scale-up and implementation of the technical drug product manufacturing processes at GMP DP manufacturing site(s) and provide technical on-site support
Responsible for process implementation and technical transfer documentation
Drive GMP change management strategy of assigned projects as well as initiate and manage GMP change control in system
Lead and support critical GMP product / process deviations and corresponding implementation of corrective/preventive actions (CAPAs)
Ensure all activities are performed according to current standards (Good Manufacturing Practice (cGMP), Health Safety Environment (HSE), Regulatory, etc.)
Enable innovation and technical strategy projects, generate IP and contribute to scientific publications and conference talks, and evaluate and implement of new methods and technologies
Key requirements:
PhD. or equivalent experience in pharmaceutical sciences, pharmaceutical engineering, chemistry, biochemistry, or related fields or similar qualification
Extensive experience in biotech / pharma industry
Knowledge of technical issues and requirements for drug product technical transfers
Know-how in aseptic product manufacture for protein drug products desirable including lyophilization process, manufacturing experience in prefilled syringes is an asset
Excellent communication skills with great teammate attitude
Very good planning and organizing skills, including project management, risk management and technical writing 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.
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