Product Technical Specialist

Join us at Alexion Technical Operations (ATO), where we collaborate with a network of internal sites and external manufacturing partners, alongside Development, Quality, Regulatory, Supply Chain, and Commercial Operations teams. Our mission is to provide technical leadership that ensures the delivery of quality products to patients and supports our product pipeline. As a Product Technical Specialist, you will play a crucial role in supporting the technical leadership of Alexion’s commercial products and late-stage clinical assets throughout their lifecycle. You will work closely with various departments to ensure regulatory compliance and best-in-class technical manufacturing processes.

Accountabilities

As a Product Technical Specialist, you will:

• Provide technical support for assigned (bio)pharmaceutical products, focusing on drug substance, raw materials, drug product packaging, and associated testing.
• Implement optimizations and standardizations across products.
• Utilize digital platforms for data analysis such as JMP, Discoverant, Power BI, Smartsheet, and AI.
• Maintain knowledge and history repositories for products and processes throughout their commercial lifecycle.
• Support lifecycle product changes for drug substance and drug product internally and across the contract manufacturing network.
• Lead change control generation and implementation using established Quality Management System (QMS) procedures.
• Support deviation initiation, investigation, and completion using QMS procedures.
• Author and edit documents in the Alexion Electronic Document Management system (eDMS) and Technical Memo library.
• Draft risk assessments and update technical risk registers for ATO.
• Generate and review SOPs, job aids, protocols, and reports.
• Assist in the preparation and monitoring of process capability analysis.
• Create and own metrics while supporting procurement activities.
• Support inspections by creating storyboards and playbooks for ATO.

Essential Skills/Experience

• Degree in scientific or engineering subject area with minimum 3 years’ experience in (bio)pharmaceutical manufacturing/development/process engineering
• Good communication and technical writing skills
• Be technically curious, challenging current assumptions to ensure the most efficient and scientifically sound approach to technical challenges is implemented
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others, maintain general availability during standard business hours

Desirable Skills/Experience

• Experience of statistical analysis, and software packages (e.g., JMP) is beneficial
• Proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint
• Knowledge of pharmaceutical lifecycle management and associated Regulatory approaches

At AstraZeneca's Alexion division, we are at the forefront of rare disease biopharma, pushing the boundaries of science to translate complex biology into transformative medicines. Our unique position with global reach allows us to shape the future of rare disease treatment. We foster an environment where innovation thrives, supported by a culture that values diversity and connection to patients' lived experiences. Here, your career is not just a path but a journey to make a meaningful impact.

If you're ready to be part of a team that is making a difference in the lives of patients with rare diseases, we’d love to talk.

Date Posted

29-Apr-2025

Closing Date

12-May-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.