Advanced Gene Therapy Bioprocessing Expert

The primary objective of this role is to act as a subject matter expert and responsible manufacturing professional for an area of bioprocessing. Key responsibilities include advanced manufacturing for the production of sterile gene therapy products and/or plasmid DNA in line with current Good Manufacturing Practice (cGMP) requirements.

• Ownership and accountability for a designated bioprocessing stage, acting as site Subject Matter Expert (SME), to ensure compliance with cGMP regulations.
• Supervision and coordination of Bioprocessing Scientists during shifts, with the ability to deputise for Team Leader when required.
• Development and implementation of training approaches for technical and support activities within Manufacturing, ensuring quality execution.
• Execution of manufacturing activities following all GMP instructions and good practices to produce high-quality products.
• Leadership of Quality issue rapid response during bioprocessing, and independent root cause analysis investigations for all classifications of deviation.
• Development and implementation of Quality Risk Assessments and Change Control for the area of responsibility.
• Promotion of continuous improvement initiatives to address recurring deviations, process yield opportunities, and other initiatives that enhance quality, safety, and supply reliability within the area of responsibility.
• Maintenance of a clean room environment to achieve the required level of low bioburden / aseptic operations.
• Sanitisation of manufacturing materials and facility as needed.
• Ensuring correct, clean, appropriate, and ready-for-manufacture materials are in place according to the agreed schedule.
• Compliance with GMP, Data Integrity, and Good Documentation Practice (GDP) for own work, undertaken in accordance with applicable procedures.
• Timely completion of own training in a GMP-compliant manner before undertaking tasks.
• Closure of assigned GMP documentation, such as Issues, CAPAs, Change Controls, BMRs & audit/inspection actions in a timely and RFT state.

• Safe working practices by self and others.
• Compliance with GMP requirements including Data Integrity.
• Excellent cleanroom behaviour.
• Timely closure of GMP and EHS commitments inside and outside of the cleanroom.
• Proactive coordination of activities to deliver adherence to the manufacturing schedule.

• Management and oversight of advanced biochemical drug substance manufacturing to cGMP requirements.
• Operational health and safety management in a dynamic and changing environment.
• Strong organisational skills, planning, and risk management to ensure manufacturing and project commitments are achieved on time and in full.
• Strong analytical mindset, synthesising complex information, using intuition and experience to complement data, and assessing and managing risks formally.
• Experienced structured problem solving, identifying and resolving problems effectively and urgently, gathering and analysing information skillfully, developing alternative solutions, and working well in cross-functional teams for problem solving.
• Fostering a continuous improvement mindset and capability within and across teams.

• A minimum of 5 years of hands-on experience in biopharmaceutical manufacturing, preferably with a strong focus on gene therapy, plasmid DNA, or viral vector production.
• Comprehensive understanding of upstream and downstream bioprocessing operations, including fermentation, purification, and aseptic techniques.
• Quality events management, including root cause analysis and resolution of deviations, as well as managing CAPAs, change controls, and quality improvement initiatives.
• Leadership skills, with experience leading and mentoring a team of bioprocessing operators, providing daily guidance, task allocation, and performance feedback.
• Problem-solving abilities, with a strong analytical mindset capable of troubleshooting process issues and implementing effective solutions under GMP-compliant conditions.
• Regulatory knowledge, familiarity with GMP regulations and guidelines, ensuring compliance during all manufacturing activities.
• Cross-functional collaboration, ability to effectively collaborate with QA, QC, Technical Transfer, and other teams to support manufacturing activities and address process improvements.
• Communication skills, strong written and verbal communication skills for preparing documentation, training operators, and presenting findings during meetings.
• Innovation and continuous improvement, a proactive approach to driving process optimisation and contributing to the development of more efficient manufacturing practices.