Senior Technical Transfer Specialist
Join a Leading Biopharmaceutical facility in Cork as part of the growing Engineering team. This role involves leading, collaborating, and facilitating activities such as scale-up, PPQ batch manufacture, license submissions, technical troubleshooting, and audit readiness for Technology Transfer.
Job Description
As a Senior Technical Transfer Specialist, you will be responsible for ensuring the effective and efficient on-time delivery of activities to the Vaccines Integrate Process Team (IPT). You will work with colleagues on site and globally on multiple technical projects, bringing energy, knowledge, and innovation to carry out the following:
* Ensure the highest Quality, Compliance, and Safety standards primarily with Technology Transfer but relating to all activities.
* Work within a team to enable the team's performance within the Vaccine Technology Transfer group in the Technical Operations Department.
Responsibilities
Key responsibilities include:
* Technical Review, ownership, and approval of Change Control, Quality Notification, deviation, and investigation records as required.
* Benchmarking and remaining current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise.
* Stakeholder management of multiple decision makers, corporate colleagues, cross-functional teams, and demonstrating ability to maintain and strengthen trust relationships with people at all levels.
Requirements
To be successful in this role, you will need:
* Honours Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
* Project management qualification such as Project Management Professional is desirable.
* Predominance of Lean Six Sigma qualification or experience of application of Lean principles.
Experience
Desirable experience includes:
* 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.