Associate Director of Manufacturing Science & Commercial Supply

Location: College Park, Dublin

Competitive salary and benefits

Opening date: 29/11/2024

Closing date: 15/12/2024

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals and the supply of healthcare services. However, we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energised, and rewarded for their ideas and creativity.

We are building a next-generation active pharmaceutical ingredient (API) manufacturing facility for small molecules near Dublin, Ireland. This is a launch facility that will help us optimise our work and improve our efficiency. It will use cutting-edge process technology and digital innovations to meet the needs of AstraZeneca's exciting new pipeline! We are taking bold actions to create new ways to make life-saving medicines through a digital smart and paperless factory. With great innovation, we are changing the ways APIs are being manufactured, so we can produce them continuously. By doing this, we can deliver medicines to patients faster, cheaper, and more sustainably. We aim to have the facility up and running by early 2026. Construction is underway at the site next to our Alexion offices in College Park, Dublin.

Pharmaceutical Technology and Development (PT&D) are the bridge that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines and commercialisation of products. Chemical Development is responsible for the route design, process development, and lifecycle management of Active Pharmaceutical Ingredients. AstraZeneca has over 60 commercial APIs.

We are currently recruiting for an Associate Director to join our multi-skilled Manufacturing Science and Commercial Supply (MSCS) group, which is dedicated to the technology transfer and lifecycle management of commercial active pharmaceutical ingredients (API) at AstraZeneca. The drivers are to ensure robust technology transfer, validation, and manufacturing to maintain continuity of supply and ensure license to operate. We also strive to continue delivering business value through optimization and redesign of manufacturing processes and controls, alongside new supply chain design. AstraZeneca currently manufactures a high percentage of commercial API externally with CDMOs, so we are excited about the opportunity to internalise small molecule manufacture for launch.

In this role, you will lead a multidisciplinary team at our new API commercialisation facility, contributing valuable manufacturing expertise to chemical development project teams. Your team will play a crucial role in transferring and optimising new processes to establish robust and sustainable technologies, thereby securing our commercial drug substance supply. This includes ensuring the right first-time technical transfer of our new drug substance manufacturing processes into the facility and out to our manufacturing partners, both internal & external.

Accountabilities

• Lead and manage the personal development, performance, and delivery of a multidisciplinary team of scientists and engineers developing drug substance manufacturing processes.
• Team responsibilities include scientific leadership to deliver:
• Development and optimization of new processes and support of technology transfer
• Effective and agile delivery of right first-time processes, with an understanding of receiving site capabilities and a particular focus on critical process attributes.
• Provide first-line support for manufacturing issues, bringing process-specific insight and leveraging the wider chemical development network expertise.
• Optimal knowledge management of process developments and performance in manufacturing.
• Lead the startup of and then ongoing activities in the chemical development laboratories, ensuring compliance with SHE regulations.
• Implement and champion the use of digital tools to enhance and accelerate the process tech transfer into and out of the facility.
• Build strong connections with the wider chemical development organization, sharing manufacturability insights to strengthen our process development workflows.
• Define, prioritize, and support the introduction of new technologies into the facility.
• Manage RDI grant process and stakeholder expectations.
• Represent the chemical development function at the APICOM leadership team.

Essential Skills/Experience

• Minimum degree in relevant scientific discipline (e.g., Organic Chemistry, Chemical Engineering).
• Significant experience in pharmaceutical drug substance development and manufacture.
• Proven track record in process design, new product introduction, and process optimization.
• Strong leadership skills, with track record of building high performing teams and developing team effectiveness
• Proven experience of technical guidance, training and supervision of teams, with acknowledged coaching and mentoring skills.
• Experience in managing technical laboratories with a focus on drug substance processes.
• Excellent communicator with the ability to influence and share strategic messages across functional boundaries, to challenge the status quo and continually seek opportunities for novel work practices.
• Thorough understanding of regulatory submissions, SHE, and cGMP.
• Proven problem solver with in-depth technical skills and a drive for continuous learning and development.

Desirable Skills/Experience

• Strong understanding of digital tools for enhancing tech transfer.
• Experience of supporting external collaborations in the development of new technologies, including upskilling students and guiding the science to ensure the collaborations deliver full potential.
• An established track record of enhancing business reputation through scientific publications as contributor or author in peer-reviewed journals, patents, external talks, and presentations.
• Awareness of Lean thinking and tools to drive productivity.

When we put unexpected teams in the same room, we unleash 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.

AstraZeneca offers an environment where you can thrive with standardised ways of working driven by Lean principles. Embrace creativity, dig deep into problem-solving together as a team, and drive efficiencies through our processes while focusing on what truly matters.

Ready to make a significant impact? Apply now!

Date Posted

29-Nov-2024

Closing Date

14-Dec-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.