Senior Technical Transfer Specialist
We are seeking a Senior Technical Transfer Specialist to join our growing Engineering team at a leading multi-national Biopharma company.
Key Responsibilities:
* Ensure Quality, Compliance, and Safety standards through Technology Transfer and related activities.
* Collaborate with the team to optimize performance within the Vaccine Technology Transfer group in the Technical Operations Department.
* Conduct technical reviews and approve Change Control, Quality Notification, deviation, and investigation records as required.
* Input into technical planning and decisions for the Vaccines integrate process team to ensure supply of high-quality product.
* 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 the development of new technologies in the vaccine and biopharmaceutical processing field of expertise.
Requirements:
* 6 years + of experience in a biopharmaceutical/vaccine environment.
* BSc or Masters in a Science or Engineering discipline (preferably Biotechnology).
* Project management qualification is desirable.
* Lean Six Sigma qualification or experience in the application of Lean principles is desirable.
* Demonstrated knowledge in one or more pharmaceutical or biopharmaceutical manufacturing operations.
* Knowledge of regulations and applicable standards for Quality, Safety, and Regulatory within the biopharmaceutical/vaccine area.
* Demonstrated successes working in a cross-functional team environment.
* Demonstrated high level of problem-solving skills.
* Experience in an FDA/HPRA regulated production environment.
* Stakeholder management of multiple decision-makers, colleagues, and cross-functional teams.