Associate Principal Scientist – Right Particle Project Expert

Macclesfield, UK

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 believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a phenomenal place to work and have a culture that encourages innovation and collaboration. We empower our colleagues to 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 our patients. We combine people’s technical knowledge and understanding with their talent and drive to design, develop and optimise synthetic routes that deliver the active pharmaceutical ingredients of our medicines in a sustainable, commercially viable way. We believe in innovation and continuous improvement, working closely with colleagues in academia and across industry, to ensure that we apply the newest technologies and principles in the processes we develop.

We have an open position for an Associate Principal Scientist in our vibrant Right Particle community.

As an Associate Principal Scientist, you will be a scientific leader in our growing crystallisation and particle engineering community across Chemical Development. Together with teams of colleagues in other departments and skill areas you will design, develop, optimise and scale-up challenging processes to robustly deliver drug substance with desired physicochemical attributes for drug product. You will also plan and drive improvement projects, use new technologies or modify our ways of working within AstraZeneca or externally with our Contract Development and Manufacturing Organisations (CDMOs).

Key responsibilities include:

• Lead or contribute to complex projects focusing on sustainable process development and manufacture of drug substances and provide the link through to Drug Product.
• Provide technical crystallisation and particle engineering expertise in process development and scale-up, manufacturability and control strategy for drug substance and intermediates as an integral part of route and process development phases.
• Drive the sustainability of right particle process development with respect to environmental impact, efficiency and cost.
• Act as a scientific expert to initiate, drive and deliver science and technology strategy and other improvement activities both internal and external to the Chemical Development department.
• Tackle and provide technical leadership for complex scientific problems.
• Work collaboratively with colleagues in Drug Product Development to identify and define the required particle properties for downstream processing.
• Drive the Drug Substance control strategy, ensuring processes are fully understood and will robustly deliver consistent drug substance quality and align with Drug Product control strategy.
• Deliver Chemistry Manufacturing and Controls (CMC) content and contributions to regulatory filings throughout the clinical development phase and commercial launch.
• Develop an external network (industrial and academic) to bring learning and innovative crystallisation and particle engineering science into AstraZeneca.
• Mentor and develop junior colleagues of multiple skill-areas.

Essential requirements:

• A degree and / or PhD in Chemistry or Chemical Engineering.
• Significant industrial experience and a proven track record as a scientific leader in crystallisation/particle process development.
• Have the ability to manage and prioritise a complex portfolio of projects as Right Particle leader.
• Have the ability to provide experienced technical direction to colleagues at all stages of development of crystallisation and particle engineering processes, including technical transfer and validation, as an integral part of drug substance route development.
• Have the ability to provide support for the development and delivery of intermediates and API particle processes internally & externally.
• Experience of working with Contract Development and Manufacturing Organisations (CDMOs).
• Have the ability to work collaboratively with colleagues in Drug Product Development in multi- functional teams to define desired particle properties for formulations, manufacturability and bioavailability.
• Align and deliver consistently to the drug substance control strategy ensuring API quality through into drug product development.
• Drive the use of Performance-based API Quality Attributes tools and embed improved Ways of Working at the drug substance & drug product interface.
• Expertise in a range of particle/materials/ solid state characterisation techniques.
• Expertise in a range of inline Process Analytical Technology (PAT).
• Interpreting, reviewing and reporting data from own work and external partners’, drawing authoritative conclusions and recommendations.
• Lead and/or work as a member of multi-functional teams, with a large degree of independence representing own department or area of expertise.
• Proactive stakeholder awareness and management including strong communication, presentation and influencing skills.
• Continuously develop yourself and your colleagues via training and shared learning to improve our efficiency and effectiveness.
• Ensuring own work is performed in accordance with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Manufacturing Practice (GMP).

Desirable Skills & Experience:

• Experience of working in the Pharmaceutical or Fine Chemicals Industry.
• Authoring of RFPs for delivery of crystallisation/particle engineering processes.
• Knowledge of particle size reduction unit operations.
• Experience of development and manufacturing of non-crystalline or large molecule entities.
• Experience of development and manufacturing platforms for continuous particle forming processes.
• Exposure and utilisation of modelling software (e.g. gPROMS FormulatedProducts, PharmaMV, Aspen, DynoChem) to support and inform process development and understanding.
• Experience in technology transfer and commercial production.
• Experience of working with external partners, such as academia, investigating a new technology or processes and implementing these within the company.
• Experience of delivery of CMC content and contributions to regulatory filings throughout the clinical development phase and commercial filings.
• Experience and understanding of pharmaceutical drug project management.

Please note that applications must include your current CV and a cover letter and be submitted before midnight on November 9th 2023.

Date Posted

Closing Date

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.