Senior Technology Transfer Lead

Senior Technology Transfer Lead

Lonza

Basel, Switzerland

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:

• 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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