Chemical Development – Drug Substance Analytical Project Expert in Manufacturing Science and Commercial Supply
Macclesfield (UK)
Are you passionate about drug substance development and eager to apply your expertise in a company that follows the science and turns ideas into life-changing medicines? If so, AstraZeneca might be the one for you!
We are a global, innovation-driven biopharmaceutical company that not only focuses on the discovery, development, and delivery of life-saving medicines but also believes in sustainability and minimizing our environmental impact. Join us and be part of a culture that inspires innovation and collaboration. We empower our colleagues to be their authentic selves, express diverse perspectives and at the same time feel valued, respected and rewarded for their ideas and creativity.
Chemical Development:
In Chemical Development we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to patients. Focussed on late stage (Phase 2/3) and commercial drug substance, we combine technical knowledge and understanding with individual talent to define the commercial control strategy, drive design, development, and optimisation of synthetic routes and analytical methodologies that deliver medicines in a sustainable, commercially viable way. As a department delivering scientific excellence, we are focussed on innovation, continuous improvement, sustainability, automation and lifelong learning.
As part of the Manufacturing Science and Commercial Supply (MSCS) group within Chemical Development, we are dedicated to the lifecycle management of commercial active pharmaceutical ingredients (API) at AstraZeneca. We maintain continuity of supply, ensure license-to-operate and continue to deliver business value through optimisation of manufacturing processes, methods and supply chain design.
Accountabilities:
- Leading the drug substance authoring and providing a significant contribution to regulatory submissions and responses to health authority questions to global markets.
- Providing expert technical input to change control, deviations and out of specification investigations at CMOs and internal AZ API manufacturing sites, linking understanding to assess the impact of changes on control strategy and analytical measurements.
- Directing/influencing external organisations (CMOs) towards successful improvements such as increasing analytical method robustness, decreasing the analytical contribution to process variability and reducing environmental impact.
- Developing improved control strategies aligned to second generation manufacturing changes.
- Leading analytical technology transfers between suppliers.
- Representing Chemical Development as lead analyst on CMC Project delivery and Global Supply Teams to ensure compliance/license to operate, security of supply and supporting improvements and changes to the supply chain, analytical methods and manufacturing process.
- Leading a small matrix team of analysts on a project
- Defining and communicating technical requirements for manufacturing process and equipment for input to selection of new suppliers.
- Executing or providing support and technical direction for any technical/experimental work required during investigation and definition of corrective and preventative actions.
- Coaching and developing junior colleagues, supporting them in reaching their full potential.
- Identifying and solving potential issues and acting as an interface between departments.
- Ensuring, with respect to technical standards that changes to pharmacopeia are implemented at all manufacturing sites.
- Providing expert internal consultation on the commercialisation of pharmaceutical processes.
- Contributing to the development of the commercial strategy to support AZ current and future portfolio, defining, and delivering continuous improvement plans.
All these activities will have a significant impact on the speed, quality, cost and environmental impact of the AZ commercial portfolio, the overall success of the Supply Chain as well as ensuring the commercial viability and reducing carbon footprint of the medicine. The role, therefore, has a significant impact on both financial and reputational aspects of the business.
Essential Skills/Experience:
• BSc/PhD level education in a relevant discipline
• Significant experience working within a Research & Development and Manufacturing environment, within the pharmaceutical industry
• Good understanding of the overall drug development process from discovery through to launch
• Experience of technical supervision, coaching, and mentoring or leading small teams of people or scientific projects
• Understanding of key analytical techniques, (for example, HPLC, GC, NMR, etc.)
• Excellent communication and strategic influencing skills
• Experience as a lead analyst in project teams
• Thorough understanding of the principles and management of SHE and cGMP
• Significant experience of delivering CMC content or contributions to regulatory filings
Desirable Skills/Experience:
• Ability to think and operate across functional boundaries
• Ability to analyse and interpret complex situations
• Experience and skilled at facilitation at all levels
• Proven problem solver with in-depth technical skills
• Proficiency in the use of statistics to understand data
• Experience of supporting commercial manufacture and working with contractors
• Experience of late-stage development with a background in an analytical skill group
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.
At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. We are part of an inclusive community that supports each other on our journeys. We are intellectually stimulated by constant learning. There's potential for multiple, global careers and great rewards, for those who embrace the diverse opportunities.
Ready to make a positive impact? Join us in Operations where we have a big ambition: to deliver more medicines to patients, quicker and more affordably. 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.