Major Activities

• Ensure on-time availability of GMP product manufactured according to the agreed manufacturing schedule.
• Work collaboratively across departments to deliver manufacturing performance targets and to solve. problems and remove barriers constraining performance and improvement.
• Line manage a team of Bioprocessing Scientists and Manufacturing Technicians providing training, support, motivation, coaching, development and performance management. Responsible for coordinating, organising and supporting the training of the team and the personal development of our team members.
• Responsible for ensuring the team understand the relevant safety hazards and controls for their area, that all activities are risk assessed before performing them, and that the team is protected from all potential risks.
• Responsible for ensuring Quality On The Shop Floor (QOTSF) is in place and executed to the defined schedule to verify our facility is inspection-ready at all times. Responsible for ensuring actions identified from QOTSF activities are tracked and delivered in a timely manner. Lead local area self inspection program to ensure "always Inspection ready".
• Responsible for leading Quality issue first response during bioprocessing.
• Effectively communicate business and operation goals, progress and updates within team.
• Responsible for inspection readiness at all times and responsible for leading Inspection/Audit tours of the manufacturing facility.
• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a right-first-time state.
• Champion continuous improvement within the team, providing coaching and support for team members and maintaining the continuous improvement system for the team.
• Responsible for setting and confirming high standards for quality critical manufacturing activities including but not limited to cleanroom behaviour, housekeeping, environmental monitoring, cleaning, and materials handling.
• Oversight of Contract Cleaning Technicans alongside the SSE Supervisor to ensure all GxP requirements are achieved.

Key Performance Indicators

• Prevention of injuries and incidents across the manufacturing facilities.
• Timely closure of GMP commitments (regulatory, deviations, CAPA, change Control).
• Adherence to manufacturing and supply schedule.
• Delivery of product development, clinical and launch manufacturing milestones.
• Positive regulatory inspection outcomes.
• High employee engagement and talent retention.

Key Job Competencies

• Management and oversight of advanced biochemical drug substance manufacturing to cGMP requirements.
• Management of operational health and safety in a dynamic and changing environment.
• Leadership, coaching and development of operational and technical teams with high potential individuals in organizations undergoing significant growth and change.
• Strong organisation skills, planning and managing risk effectively to ensure manufacturing and project commitments are achieved on time and in full.
• Strong analytical mindset, synthesizes complex information, uses intuition and experience to compliment data.
• Creation and embedding performance systems, establishing workflows and procedures built on simplicity, reliability and effectiveness.
• Experienced with structured problem solving, identifies and resolves problems effectively and urgently; gathers and analyses information skilfully; develops alternative solutions; works very well in cross functional teams for problem solving.
• Fosters a continuous improvement mindset and capability within and across teams.

Job Responsibilities

• Lead a team of up to 12 Bioprocessing Scientists with additional supervision of embedded contract workers.
• Accountable for GMP approval of documentation and activity within a licensed Advanced Therapeutical Medicinal Product (ATMP) facility.
• Accountable for GxP compliance within bioprocessing areas.
• Accountable for safety of bioprocessing team and areas.

Job Background

• BSc in Biotechnology with a strong academic foundation in life sciences.
• Robust experience in GMP-compliant manufacturing operations, with hands-on involvement in ATMP and biologics production environments.
• Demonstrated expertise in quality systems, deviation management, and process improvement across the biopharmaceutical lifecycle.
• Proven track record in supporting regulatory inspections (e.g., HPRA, FDA) and leading audit readiness and compliance-driven initiatives.
• Skilled in cross-functional collaboration between manufacturing, QA, and process development teams/