Principle Scientist Drug Product, Alexion Technical Operations

Overview
This is what you will do:
Responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by Alexion for production of commercial products.
This position provides strong scientific leadership for all aspects of manufacturing, validation, process scale-up, inspections, process monitoring, and process troubleshooting for drug product manufacturing activities.
The position fosters effective cross-functional working relationships with internal and external groups in operations, Process Development and Analytical Sciences for the support of commercial Drug Product manufacturing processes.
The role provides support for Regulatory submissions related to commercial products manufactured at CMOs.
You will be responsible for:
Provide technical and scientific direction for the production of drug product at CMOs.
Provide technical leadership and direction for transferring new products and processes.
Provide input to Technical Services project schedule on a weekly, monthly, and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet corporate goals and metrics, as required.
This includes continuous communication with internal partners (Quality Assurance, Supply Chain, Process Development and Analytical Sciences) to ensure efficient management of Alexion's commercial product manufacturing.
Support risk assessments in support of new product implementation and provide direction and significant technical input for DFM (Design for Manufacturability) initiatives.
Plan and manage day-to-day technical support work to meet manufacturing or CMO shutdown schedules while supporting a high level of GMP compliance at the CMOs.
Provide technical input to Process Development for defining the critical process parameters of new processes.
Author/review technical documents for regulatory agency submission in support of process transfers.
Serve as a subject-matter expert on drug product manufacturing and process support during regulatory agency inspections.
Provide technical leadership and direction for process monitoring and statistical analysis of manufacturing operations.
Provide significant technical depth to support troubleshooting efforts and lead high-level deviation investigations in conjunction with Alexion QA and CMO Manufacturing and Quality groups.
Identify and lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of Manufacturing.
Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail.
Communications will be both written documents and oral presentations.
Up to 20% international travel may be required
You will need to have
Comprehensive understanding of Technical/cGMP requirements for commercial manufacturing of Drug products.
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.
Advanced degree in engineering or comparable industry experience
We would prefer for you to have
Knowledge of lyophilization and filling of different modalities
Knowledge of medical combination devices filling such pre-filled cartridges and syringes.
Date Posted
26-Aug-2025
Closing Date
25-Sep-2025
Our 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.
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