Senior Tech Transfer Specialist

3 days ago

Cork, Ireland Tandem Project Management Limited Full time

Senior Tech Transfer Specialist Summary: Our client is a biopharmaceutical company based in Cork looking for a Senior Tech Transfer Specialist to lead, collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, license submissions, technical troubleshooting and audit readiness) for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to the team. 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 the team. Input into/lead technical planning and decisions for the team, to ensure the 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 the 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, and cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels. Qualifications & Experience: Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology). Project management qualification such as, Project Management Professional is desirable. Preference for Lean Six Sigma qualification or experience of application of Lean principles Minimum 6 years experience in biopharmaceutical/vaccines environment. Experience of leading projects; leading technical projects is distinct advantage. Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area. Demonstrated knowledge in one or more pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing operations, technology, validation, engineering, quality). Experience in a FDA / HPRA Regulated production environment. Skills: Project Management Professional FDA HPRA Quality Safety Lean Six Sigma

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