Ref. 01253
Senior Technical Transfer Specialist
Exciting Opportunity for a Senior Technical Transfer Specialist.
Our client, a leading multi-national Biopharma company based in Brinny, Co. Cork, is seeking a Senior Technical Transfer Specialist to join their growing Engineering team. Primary responsibilities include leading, collaborating, and facilitating activities such as scale-up, PPQ batch manufacture, licence submissions, audit readiness, and technical troubleshooting for Technology transfer of processes to ensure efficiency and effective delivery of these activities.
As part of this team, you will play a significant role, working with colleagues on-site and globally on multiple technical projects.
Responsibilities
1. Ensure the highest Quality, Compliance, and Safety standards primarily with Technology Transfer but relating to all activities.
2. Collaborate within a team to optimize performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
3. Conduct technical reviews, ownership of and approval of Change Control, Quality Notification, deviation, and investigation records as required.
4. Input into Technical planning and decisions for the Vaccines integrate process team to ensure the supply of high-quality product through tactical planning and execution of production schedules.
5. Recommend technical approaches in line with global and local standards.
6. Responsible for the technical transfer and scale-up of a new process into the Vaccines integrate process team.
7. 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.
8. Stakeholder management of multiple decision-makers and corporate colleagues, demonstrating the ability to maintain and strengthen trust relationships with people at all levels.
Requirements
1. 6 years + of experience in a biopharmaceutical/vaccine environment.
2. A BSc or a Masters in a Science or Engineering discipline (preferably Biotechnology).
3. Project management qualification is desirable.
4. Lean Six Sigma qualification or experience of application of Lean principles is desirable.
5. Demonstrated knowledge in one or more pharmaceutical or biopharmaceutical manufacturing operations (e.g. manufacturing operations, technology, validation, engineering, quality).
6. Knowledge of Regulations and applicable standards for Quality, Safety, and Regulatory within the biopharmaceutical/vaccine area.
7. Demonstrated successes working in a cross-functional team environment, such as project teams.
8. Demonstrated high level of problem-solving skills.
9. Experience in an FDA / HPRA Regulated production environment.
10. Stakeholder management of multiple decision-makers, colleagues, and cross-functional teams.
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