Drug Substance Analytical Project Lead in Manufacturing Science and Commercial Supply (MSCS) - Chemical Development

Location: Macclesfield, UK

Competitive salary and benefits

Opening date: 27/11/2024

Closing date: 11/12/2024

Do you have expertise in, and passion for drug substance development? Would you like to apply your expertise to impact analytical science in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, innovation-driven biopharmaceutical company, where we not only focus on the discovery, development, and delivery of life-saving medicines to our patients but also believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to have 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.

Pharmaceutical Technology & Development:

Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into 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 – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Drug Substance 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. Focused 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 focused 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. As a drug substance analytical project lead, you may also provide support for clinical development project teams starting validation and commercial submission authoring.

Accountabilities

As an experienced analytical scientist and project lead, you will have accountability for leading analytical packages of work to maintain and optimize supply for one or more AstraZeneca commercial products meeting cost, quality, and environmental targets.

• Drug substance authoring and providing a significant contribution to regulatory submissions and responses to health authority questions to global markets.
• Providing 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.
• Influencing external organizations (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.
• Defining and communicating technical requirements for manufacturing processes and equipment for input to the 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.
• Some coaching and developing junior colleagues is expected.
• 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.
• Contributing to the development of the On-Market strategy to support AZ's 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 the 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 and experience working within a Research & Development or Manufacturing environment, within the pharmaceutical industry.
• A good understanding of the overall drug development process through to launch.
• An understanding of key analytical techniques (for example, HPLC, GC, NMR, etc.)
• Excellent communication and strategic influencing skills across interfaces of discipline, culture, and both internal and external project teams.
• Experience as a lead analyst in project teams desirable
• A thorough understanding of the principles and management of SHE and cGMP.
• Experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process or formulation analytical development in the pharmaceutical industry.
• Ability to think and operate across functional boundaries, challenge the status quo, and seek opportunities for business improvement.
• Ability to analyse and interpret complex situations and provide clear strategic directions for others.
• Proven problem solver with in-depth technical skills.
• Demonstrate a high degree of personal credibility and end-to-end supply chain thinking.
• 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.

In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.

Ready to make a difference? Apply now!

Please note applications must include your current CV and cover letter which details your key areas of strength / development and why you should be considered for the role. Interviews will take place in January 2025.

Date Posted

27-Nov-2024

Closing Date

10-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.