Senior Technical Transfer Specialist
We are seeking a Senior Technical Transfer Specialist to join our growing Engineering team. This role will lead, collaborate and facilitate activities such as scale-up, PPQ batch manufacture, license submissions, audit readiness and technical troubleshooting for technology transfer of processes.
Key Responsibilities:
* Ensure Quality, Compliance and Safety standards in Technology Transfer and all related activities.
* Collaborate with the team to optimize performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
* Conduct technical reviews, approval of Change Control, Quality Notification, deviation and investigation records.
* Input into technical planning and decisions for the Vaccines integrate process team.
* Recommend technical approaches in line with global and local standards.
* Responsible for the technical transfer and scale-up of a new process into the Vaccines integrate process team.
* Benchmark and remain current with new technologies in vaccine and biopharmaceutical processing.
Requirements:
* 6+ years experience in biopharmaceutical/vaccine environment.
* BSc or Masters in Science or Engineering discipline (preferably Biotechnology).
* Project management qualification desirable.
* Lean Six Sigma qualification or experience in Lean principles desirable.
* Demonstrated knowledge in pharmaceutical or biopharmaceutical manufacturing operations.
* Knowledge of regulations and applicable standards for Quality, Safety and Regulatory.
* Successes working in cross-functional team environment.
* High level of problem-solving skills.
* Experience in FDA/HPRA regulated production environment.
* Stakeholder management of multiple decision-makers, colleagues and cross-functional teams.