Senior Manager, MS&T, Drug Product

Senior Manager, MS&T, Drug Product, fixed term contract / remote

Job Spec :

This fixed term contract role, reports into the Director, MS&T.

• This role bridges technical expertise and operational leadership within MS&T, specialising in Drug Product (DP) operations.
• The role works in close collaboration within the external manufacturing operations team and the New products and Franchise Lead within MS&T.
• The role will provide strong scientific and technical leadership and oversight for Technical Transfer projects between 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, realising manufacturing readiness for commercial supply, supporting risk assessment, process troubleshooting, drug product manufacturing activities for Aseptic Drug Product.
• Other responsibilities will include cross-functional team leadership and / or membership, authoring technical reports and supporting aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including Pharmaceutical Development, RA CMC, and Quality, working towards existing and new product integrations, and ensuring all processes are understood, robust, efficient and in control.
• The role will also require delivery of projects through external partners, with ownership of internal activities for oversite and related supporting assessments & reports. Working in partnership with CMOs and ensuring projects are delivered on time, to the required standards.

Essential Functions/Responsibilities

• Act as a technical lead for aseptic DP operations, supporting technical transfers and troubleshooting.
• Lead technology transfer and scale-up projects for DP, ensuring alignment with QbD principles and regulatory expectations.
• 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.
• 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.
• Specific experience in delivering Technology Transfer Projects for the above processes
• 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.
• 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.

Person Spec

• Deep expertise in aseptic DP manufacturing process and technologies and a good working knowledge of DS biologics processes.
• Proficiency in leading and executing Technology Transfers.
• Proficiency in GMP operations, process validation.
• Strong understanding of CMC regulatory requirements and QbD principles.
• Excellent organizational, verbal, communication, presentation, and data analysis skills.
• Ability to effectively participate in multi-disciplinary teams and proficient in working with CDMO vendors.
• 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 and leading Technology Transfers.
• Proven hands-on experience in GMP manufacturing and process validation activities.
• Experience of large molecule technologies is desirable.
• Demonstrated expertise in process development, manufacturing support, validation, technology transfer, and deviation management.
• Strong knowledge of regulatory requirements, quality systems, statistical analysis, and risk management principles.
• Proven ability to influence cross-functional teams and lead technical initiatives in a complex manufacturing environment.
• Project management skills for technical programs desirable.

International Travel : 20-30%

Cv to [email protected]