Job Description
Purpose of Role: This position will provide technical support to the Vaccines IPT to support the technology transfer and scale-up of new processes for Vaccines IPT manufacture meeting the Manufacturing Division Priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. Activities Within Role: The Specialist will be required to lead, collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, licence submissions and audit readiness) in the Vaccines IPT value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to Vaccines IPT. This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment. Primary activities/responsibilities: Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities. Work within a team to enable the teams performance within the Vaccine Technology Transfer group in the Technical Operations Dept. Responsible for the technical transfer and scaleup of a new process into Vaccines IPT. 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. Technical Review, ownership of and approval of Change Control, Quality Notification, deviation and investigation records as required. 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 Job Experience > 4 years experience in biopharmaceutical/vaccines environment Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area. Qualifications Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology). Preference for Lean Six Sigma qualification or experience of application of Lean principles Project management qualification such as, Project Management Professional is desirable Evidence of Continuous Professional Development Skills: Tech Transfer Change Control Deviation