Tech Transfer Specialist

PE Global is currently recruiting for a Tech Transfer Specialist for a leading multi-national Biologics client based in Cork.

This is an initial 11-month contract position.

ROLE:

The Specialist will be required to lead, collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, license submissions and audit readiness) in the Vaccines IPT value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to Vaccines IPT.

Primary activities/responsibilities:

• 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 Dept.
• Responsible for the technical transfer and scale–up of a new process into Vaccines IPT.
• Input into Technical planning and decisions for the Vaccines IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.
• Technical Review, ownership of and approval of Change Control, Quality Notification, deviation and investigation records as required.
• Recommend technical approaches in line with global and local standards.
• Benchmark and remain current with 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.
• Contribute for driving a culture of Continuous Improvement by deploying MPS within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant.

REQUIREMENTS:

• > 3 years’ experience in biopharmaceutical/vaccines environment
• Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
• Experience of involvement in a technical project an advantage
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
• Preference for Lean Six Sigma qualification or experience of application of Lean principles
• Project management qualification such as, Project Management Professional is desirable
• Evidence of Continuous Professional Development

Interested candidates should submit an updated CV.

Please click the link below to apply,  or alternatively send an up to date CV to rebecca@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***