Major Activities

• Area ownership for a designated bioprocessing stage (Technical, Safety, Quality, Compliance, Continuous Improvement, CAPA approval, Training method) acting as site Subject Matter Expert (SME).
• Responsible for coordinating and supervising Bioprocessing Scientists when on shift, and deputising for Team Leader when required.
• Responsible for defining training approaches for technical and support activities within Manufacturing, and overseeing the quality of training execution.
• Responsible for performing manufacturing activities, following all GMP instructions and good practices to manufacture the required products.
• Responsible for leading Quality issue rapid response during bioprocessing, and independently leading root cause analysis investigations for all classifications of deviation.
• Responsible for developing and leading Quality Risk Assessments and Change Control for area of responsibility.
• Lead and prioritise continuous improvement that address recurring deviations, process yield opportunities, and other initiatives that improve the quality, safety, and eliminate waste and ensure high levels of supply reliability within area of responsibility.
• Responsible for operating appropriately within clean room environment to achieve required level of low bioburden / aseptic operations.
• Responsible for performing sanitisation of the manufacturing materials and facility when required.
• Responsible for ensuring materials used within manufacturing are correct, clean, appropriate and in place ready for manufacture to the agreed schedule.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
  

Key Performance Indicators

• Safe working of self and with 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 manufacturing schedule.

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
• 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 and to assess and manage risks formally.
• Experienced with structured problem solving, identifies and resolves problems effectively and urgently; gathers and analyses information skillfully; 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

• Responsible for GxP compliance within designated processing areas.
• Accountable for safety of self and team within designated processing areas.
  

Key Attributes/Professional Background

• Experience: Minimum 5 years of hands-on experience in biopharmaceutical manufacturing, with a strong focus on gene therapy, plasmid DNA, or viral vector production preferred.
• Process Knowledge: Comprehensive understanding of upstream and downstream bioprocessing operations, including fermentation, purification, and aseptic techniques.  Previous responsibility for "area" and "process" ownership - ideally a SME for upstream and/or downstream bioprocessing operations.
• Quality Events Management: Proven ability to handle quality events, including root cause analysis and resolution of deviations, as well as managing CAPAs, change controls, and quality improvement initiatives.
• Leadership Skills: Demonstrated experience leading and mentoring a team of bioprocessing operators, providing daily guidance, task allocation, and performance feedback.
• Problem-Solving Abilities: Strong analytical mindset with the capability to troubleshoot process issues and implement 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 optimization and contributing to the development of more efficient manufacturing practices.

Qualifications

• Educational Background: Degree in Biochemistry, Biotechnology, or a related field; advanced degree preferred but not mandatory.