Senior Specialist External Drug Product Manufacturing

Full Job Description

• The successful candidate will have technical oversight at Contract Manufacturing Organisations (CMOs) used by Alexion to produce commercial and late stage clinical drug 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.

You will be responsible for:

• Providing technical and scientific direction for Drug product 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 product
• Leading a program of improvement projects to deliver Long Range Planning (LRP) and cost of goods (CoGs) commitments for Drug product. 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

You will need to have:

• 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

We would prefer for you to have:

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

Date Posted

04-Mar-2024

Closing Date

18-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.