Senior Transfer Expert
Vor 4 Tagen
At Lonza Group Ltd., we are a global leader in life sciences operating across three continents. Our innovative approach to science is driven by talented people working together, devising ideas that help businesses to improve patient treatment.
We have exciting opportunities in our Contract Development and Manufacturing Organization (CDMO) branch located in Basel, Switzerland. As Senior Technology Transfer Lead DPS, you will be part of a group that enables its customers to meet some of the greatest challenges in patient treatment.
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.).
Requirements:
- Ph.D. or Master 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 highly desirable; manufacturing experience in prefilled syringes is an asset.
- Excellent communication skills and command of English both written and oral.
- Proven ability as team player and ability to lead cross-functional teams.
- Very good planning and organizing skills, including project management, risk management and technical writing skills.
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