Senior Tech Transfer Specialist
We are seeking a Senior Tech Transfer Specialist to lead the Technology Transfer of processes to ensure effective and efficient on-time delivery of activities to the Vaccines Integrate Process Team (IPT).
Key Responsibilities:
* Ensure 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/lead technical planning and decisions for the Vaccines IPT, to ensure the supply of high-quality product through tactical planning and execution of production schedules.
Qualifications and Experience:
* Honors 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.
This role requires a strong background in project management, technology transfer, and quality assurance. The successful candidate will have excellent communication and stakeholder management skills, with the ability to maintain and strengthen trust relationships with people at all levels.
The ideal candidate will be knowledgeable in one or more pharmaceutical or Biopharmaceutical manufacturing operation (e.g., manufacturing operations, technology, validation, engineering, quality) and have experience in a FDA / HPRA Regulated production environment.