Specialist , Technical Services Drug Product

Job Title: Specialist , Technical Services  Drug Product  

The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by Alexion to produce commercial and clinical drug products. 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. There is a strong emphasis on continuous process improvement with this role. The position also fosters effective cross-functional working relationships with internal and external groups in operations, chemical process development, analytical sciences, and quality assurance for the technology transfer of new products and providing support for regulatory submissions related to commercial and clinical products manufactured at CMOs.

Accountabilities

- Providing technical and scientific direction for technology transfer and validation drug product at CMOs.

- Ensure that all processes are appropriately validated and approved for manufacturing and partner with regulatory and quality assurance colleagues to ensure that processes are maintained in a validated and compliant state throughout their lifecycle.

- Provide guidance to process validation program for all drug product manufacturing processes at CMOs. Provide technical input to process development for defining the critical process parameters of new processes.

- Oversee process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification).

- Support the generation and review of CMC sections of the NDA/MAA and other technical documents for regulatory agency submission for commercial CMO sites.

- Offer substantial technical depth to support ongoing process improvement for growing yield and reducing cost of goods (CoGs).

- Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs.

- Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.

- Up to 20% international travel may be required.

Essential Skills/Experience

- 3- 5 years’ experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on drug product manufacture

- High level of technical expertise in pharmaceutical manufacturing across multiple technology and processing areas.

- Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.

- Broad experience of technology transfer and process validation management and continuous improvement

- Strong communication skills enabling them to influence both internal and external partners.

- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.

- Minimum undergraduate degree in a scientific team (Chemistry, Biochemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field with equivalent experience.

- An advanced degree (MS, PhD or equivalent experience) is desirable.

- Lean six sigma experience is preferred.

Desirable Skills/Experience

- Knowledge of medical/combination devices

- Exposure to/experience of Project Management principles and tools

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Joining Alexion, AstraZeneca, Rare Disease means accepting an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech. You’ll join an energizing and kind culture where people build connections to explore new ideas and learn. As a meaningful member of our commercial team, you'll be meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep, empathetic understanding of our patient's journeys, aligning your growth with our mission. You’re supported by a community of exceptional leaders and peers ready to lift you in marketing, compliance, and beyond.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.