Senior Specialist External Drug Substance Manufacturing

• The successful candidate will have technical oversight at Contract Manufacturing Organisations (CMOs) used by Alexion to produce commercial and late stage clinical drug substance product. This position provides strong scientific leadership for all aspects of technology transfer, validation, process scale-up, inspection, process monitoring, and process troubleshooting for manufacturing activities.
• As a team, we build and maintain effective cross-functional working relationships with groups in operations, process development, analytical sciences, and quality assurance (QA) for technology transfers of new and existing products and provide support for regulatory submissions related to products manufactured at CMOs.

• Providing technical and scientific direction for Drug substance manufacturing at CMOs.
• Leading troubleshooting and root cause analysis activities using best in class problem solving for critical issues at CMOs
• Using lean six-sigma expertise to identify, analyse and prioritise optimisation and yield improvement opportunities across Drug Substance
• Leading a program of improvement projects to deliver Long Range Planning (LRP) and cost of goods (CoGs) commitments for Drug substance. Leading projects within the External Technical Services group.
• Ensuring that all processes are appropriately validated and approved for manufacturing and partner with regulatory and QA colleagues to ensure that processes are maintained in a validated state and adhered to throughout their lifecycle.
• Supporting the generation and review of CMC sections of the BLA and other technical documents for regulatory agency submission for commercial CMO sites.
• Co-ordinating all aspects of process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification)
• Communicating operational status of CMOs regularly to management, as required, at the appropriate level of detail, both orally and using written documents, and in formal and informal presentations.
• Cell bank governance and ownership (usage prediction, initiating production of new WCB and evaluating stability of current WCB for use in commercial network)
• Up to 20% international travel may be required

• Previous experience in a technical or manufacturing role in the pharmaceutical industry.
• High level of technical expertise in pharmaceutical manufacturing across multiple technology and processing areas.
• Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
• Expertise in operational excellence, lean six-sigma and Project Management.
• Excellent communication and influencing skills enabling him/her to influence both internal and external partners.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Ability to trend process data and utilize statistical software i.e. JMP
• Minimum undergraduate degree in a scientific subject area (Chemistry, Biochemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field

• Exposure to Project Management principles and tools
• Experience of MS Project or other project management software

Alexion Pharmaceuticals