Director in On Market Technical (Manufacturing Design and Commercial Supply)
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical 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, energized and rewarded for their ideas and creativity.
About Chemical Development & PT&D
Pharmaceutical Technology and Development (PT&D) are the bridge, which 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 are responsible for the route design, process development and lifecycle management of Active Pharmaceutical Ingredients.
About the role
We are currently recruiting for a Director to join our multi-skilled On Market Technical group. On market technical are 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 to ensure license to operate. We also strive to continue to deliver business value through optimisation and redesign of manufacturing process and controls, alongside new supply chain design. AstraZeneca currently manufactures a high percentage of commercial API externally with CDMOs, however we are excited to be establishing a new launch facility in Dublin over the coming years. AstraZeneca have >60 commercial APIs
• Accountability for directly leading and developing a multi-skilled team consisting of chemists and analysts who have technical responsibility for activities for commercial APIs.
• Responsibility for managing the prioritisation and resourcing of the portfolio of activities within the team and inputting to the wider commercial portfolio prioritisation
Team responsibilities include scientific leadership to deliver:
o influencing process design and manufacturability of process development, optimisation and control in chemical development
o enabling right first time technology transfers with understanding of receiving site capability
o scientific assessment of changes
o monitoring of process and method performance issue resolution
regulatory maintenance (authoring or review of regulatory interactions)
continuous process and method improvement including 2nd generation processing to drive improvements in cost, lead time, sustainability and robustness
• Approval of all regulatory activities associated with assigned products
• Responsibility for developing and driving strategic initiatives to drive capability uplift to deliver AZ current and future portfolio
• Accountability for key partnerships internally and externally. Developing effective ways of working with External Supply and Manufacturing, Global Supply Chain and Strategy, Regulatory, internal manufacturing sites and our CDMOs.
The role has a significant impact on both financial and reputational aspects of the business
• Will required BSc/PhD level education in relevant subject area
• Will require significant number of year’s experience working within a Research and Development and Manufacturing environment, within the Pharmaceutical Industry
• Will require significant experience of leading and managing teams of people
• Have direct experience of Marketing Authorisations and post approval changes with a good understanding of ICH?
• Requires a thorough understanding of the principles and management of SHE and cGMP
Skills and Capabilities
• Ability to operate across functional boundaries
• Ability to analyse and interpret complex situations and provide clear strategic direction for others
• Excellent interpersonal skills and strategic influencing skills across interfaces of subject area, culture, and expertise both internally and externally
• Excellent team working and networking skills
• Strong leadership skills, with track record of building hard-working teams and developing team efficiency
• Strong analytical thinking skills as a proven problem solving
• Change management and project management skills
• Awareness of Lean thinking and tools to drive efficiency
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
Are you already imaging yourself joining our team? Good, because we can’t wait to hear from you!
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.