Bioprocessing Leadership Position

The Bioprocessing Team Leader is responsible for spearheading a team of Scientists and Technicians to enable the safe, compliant, and reliable manufacturing of clinical and commercial Advanced Therapy Medicinal Products (ATMPs) in one area of our manufacturing facility.

Job Description:

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• Ensure on-time availability of GMP product manufactured according to the agreed manufacturing schedule.">
• Work collaboratively across departments to deliver manufacturing performance targets and solve problems that constrain performance and improvement.">
• Line manage a team of Bioprocessing Scientists and Manufacturing Technicians, providing training, support, motivation, coaching, development, and performance management.">
• Coordinate, organize, and support the training and personal development of team members.">
• Ensure the team understands relevant safety hazards and controls, risk assess all activities before performing them, and protect the team from potential risks.">
• Implement Quality On The Shop Floor (QOTSF) processes to verify the facility is inspection-ready at all times. Track and deliver actions from QOTSF activities.">
• Lead local area self-inspection programs to maintain an 'always inspection ready' status.">
• Respond to quality issues during bioprocessing.">
• Communicate business and operational goals, progress, and updates effectively within the team.">
• Maintain inspection readiness and lead inspection/audit tours of the manufacturing facility.">
• Ensure compliance with GMP, Data Integrity, and Good Documentation Practice (GDP), following applicable procedures.">
• Timely and GMP-compliant training for self and team before undertaking tasks.">
• Manage GMP documentation such as Issues, CAPAs, Change Controls, BMRs, and audit/inspection actions within own area, ensuring timely closure and right-first-time quality.">
• Promote continuous improvement within the team, providing coaching and support, and maintaining the continuous improvement system.">
• Set and uphold high standards for quality-critical manufacturing activities, including cleanroom behavior, housekeeping, environmental monitoring, cleaning, and materials handling.">
• Oversee Contract Cleaning Technicians alongside the SSE Supervisor to ensure GxP requirements are met.">

Key Performance Indicators:

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• Prevention of injuries and incidents across manufacturing facilities.">
• Timely closure of GMP commitments (regulatory, deviations, CAPA, Change Control).">
• Adherence to manufacturing and supply schedules.">
• Achievement of product development, clinical, and launch milestones.">
• Positive outcomes from regulatory inspections.">
• High employee engagement and talent retention.">

Required Skills and Qualifications:

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• Management and oversight of advanced biochemical drug substance manufacturing to cGMP standards.">
• Operational health and safety management in a dynamic environment.">
• Leadership, coaching, and development of operational and technical teams, especially high-potential individuals, in a growth environment.">
• Strong organizational, planning, and risk management skills to meet manufacturing and project deadlines.">
• Analytical mindset, capable of synthesizing complex information and using intuition and experience.">
• Creating and embedding performance systems, workflows, and procedures based on simplicity, reliability, and effectiveness.">
• Structured problem solving, effective and urgent resolution of issues, and cross-functional teamwork.">
• Fostering a continuous improvement mindset and capability within and across teams.">

Benefits:

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• Job Responsibilities:">
• Lead a team of up to 12 Bioprocessing Scientists and supervise embedded contract workers.">
• Ensure GMP approval of documentation and activities within a licensed ATMP facility.">
• Maintain GxP compliance within bioprocessing areas.">
• Ensure the safety of the bioprocessing team and areas.">

Education:

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• BSc in Biotechnology with a strong academic foundation in life sciences.">
• Extensive experience in GMP-compliant manufacturing, particularly in ATMP and biologics production.">
• Expertise in quality systems, deviation management, and process improvement across the biopharmaceutical lifecycle.">
• Proven ability to support regulatory inspections (e.g., HPRA, FDA) and lead audit readiness initiatives.">
• Skilled in cross-functional collaboration between manufacturing, QA, and process development teams.">

Why Us?