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Technical Transfer Specialist Work with our client, a leading multi-national Biopharma company, in this exciting role as a Technical Transfer Specialist.
The role involves offering technical assistance to the Vaccines IPT, supporting in the technology transfer and scaling up of new processes for Vaccine manufacturing.
** the role is hybrid, typically 3 days at a minimum, 2 day remote depending on business needs etc.
Responsibilities The Specialist will lead, collaborate and oversee the execution of various activities within the Vaccines IPT. These activities include scale up, PPQ batch manufacture, licence submissions and audit readiness.
• Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities.
• Collaborate within a team to optimize performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
• Conduct technical Review, ownership of and approval of Change Control, Quality Notification, deviation and investigation records as required.
• Input into Technical planning and decisions for the Vaccines IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.
• Recommend technical approaches in line with global and local standards.
• Responsible for the technical transfer and scale–up of a new process into Vaccines IPT.
• Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
Requirements • 4 years +' experience in a biopharmaceutical/vaccines environment
• Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
• Demonstrated knowledge in technical and manufacturing operations in the pharmaceutical / biopharmaceutical field.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Previous work in a technical project is an advantage.
• Preference for Lean Six Sigma qualification or experience of application of Lean principles
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