Brief Description:

 Reporting into the Associate Director, MS&T.  

• This role bridges technical expertise and operational leadership within MS&T, specialising in Drug Product (DP) operations while maintaining experience in Biologic Drug Substance (DS).

• The role works in close collaboration within the external manufacturing operations team and the Drug Product MS&T lead who manages the MS&T team processes, tools, metrics to ensure successful manufacture and supply of product to patients.

• The role will provide strong scientific and technical leadership and oversight for projects and products through launch and the ongoing commercial manufacturing life cycle for products manufactured at Contract Manufacturing Organisations.

• The role requires strong technical oversight of manufacturing processes, including management of change controls, review and approval of batch documentation, implementation of new technologies, root cause analysis, and process troubleshooting for complex manufacturing deviations

• This position is responsible for technology transfer, process scale-up, process validation activities, process monitoring (establishing CPV), realising manufacturing readiness for commercial supply, supporting risk assessment evaluations of adopted / identified new vendors, and process troubleshooting, drug product manufacturing activities for large and/or small molecules.

Essential Functions/Responsibilities

• Act as a technical lead for DP operations, supporting lifecycle management, process monitoring (CPV), and troubleshooting.

• Provide strong technical proficiency, scientific creativity, and collaboration with others.

• Lead development, maintenance, and continuous improvements of the DP processes.

• Provide scientific input for DP processes where required, leveraging DS biologics experience for integrated solutions.

• Deeper knowledge and application of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles.

• Lead technology transfer and scale-up projects for DP, ensuring alignment with QbD principles and regulatory expectations.

• Lead process improvement projects from identification to realisation, with cross functional team and drive improvement initiatives and support risk assessments for new vendors and technologies.

• Experience of leading the technical agenda & relationship between the team and with the relevant CMOs technical team at the site of manufacture.

• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.

• Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, & influence.

• Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and procedures.

• In conjunction with Quality Operations ensure that CMOs are qualified and approved.

Required Knowledge, Skills, and Abilities

• Deep expertise in aseptic DP manufacturing process and technologies and strong working knowledge of DS biologics processes.

• Proficiency in GMP operations, process validation, and lifecycle management.

• Strong understanding of CMC regulatory requirements and QbD principles.

• Excellent organizational, verbal, communication, presentation, and data analysis skills.

• Ability to effectively participate on multi-disciplinary teams.

• Strong understanding of project management processes, risk management   processes, pharmaceutical quality management systems and pharmaceutical regulations

• Strong personal ownership for skill / technical development.

Required/Preferred Education and Licenses

• BSc in life sciences or engineering.

• Advanced degree (MSc, PhD) desirable.

• 6–8 years in pharmaceutical manufacturing with significant aseptic DP experience and exposure to biologics DS.

• Experience working in cross functional teams in a pharmaceutical industry environment.

• Record of achievement in pharmaceutical manufacturing environment.

• Proven hands-on experience in GMP manufacturing and validation activities.

• Experience of large molecule technologies is desirable.

• Project management skills for technical programs is desirable.