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 great place to work and have a culture that inspires 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.
In Chemical Development, we believe that nothing is impossible, and we are compelled 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 (APIs) 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 exciting opportunity available for a Process Engineer who will specialise in the development, optimisation and scale up of New Modality API processes. Current new modalities in the Chemical Development portfolio include oligonucleotides (naked and conjugated), synthetic peptides, dendrimers and antibody drug conjugates. The responsibilities and requirements of the position are outlined below.
As a Process Engineer on New Modality projects, you will work closely with fellow chemical engineers, chemists, analysts, colleagues from different departments and external contacts to develop, optimise and scale-up chemical processes to manufacture new modality APIs robustly and sustainably.
- Provide engineering expertise to develop and optimise new modality manufacturing processes to successfully and robustly deliver drug substances. This includes laboratory experimentation, modelling and simulation and assessment of the results obtained.
- Investigate innovative technologies to improve yield, cycle times and sustainability of new modality processes and develop these technologies for implementation at manufacturing scale.
- Carry out scale-up and manufacturability assessments of processes to ensure right first-time scale-up, technical transfer and future viability.
- Work closely with internal Supply Chain colleagues and external Contract Manufacturing Organisations (CMOs), providing engineering input into process development, technical discussions and the accommodation of processes into manufacturing facilities to deliver drug substance for clinical trials.
- Drive learning from manufactures and deliver process improvements which can be implemented in future manufactures.
- Support problem solving when issues arise during external manufactures.
- Collaborate with colleagues in Drug Product Development to understand the requirements for the physical properties of drug substances and develop processes providing these properties.
- Participate in the overall drug substance control strategy, ensuring processes are fully understood and will robustly deliver the required drug substance quality.
- Provide input to regulatory submissions including section authoring and document reviews.
- Drive technical excellence and implementation of new ways of working by developing industrial and academic networks, and contribute to the wider New Modalities scientific community.
- Mentor and supervise junior colleagues and university students.
- A degree and/or PhD in Chemical Engineering, or a relevant discipline.
- Experience of chemical process development, scale up and / or transfer of processes between manufacturing facilities.
- Strong collaborative skills and experience in working with different skillsets (e.g. with chemists, analysts and physical properties experts).
- Understanding of the requirements, principles and application of Safety, Health and Environment (SHE) regulations and Good Manufacturing Practice (GMP).
- Strong communication and influencing skills.
- Experience working in the Pharmaceutical or Fine Chemicals Industry.
- Relevant knowledge/experience for new modality projects. For example, oligonucleotide and/or peptide experience, understanding of relevant unit operations and their dependency on scale and equipment. Unit operations include: solid phase synthesis, preparative chromatography, tangential flow filtration, thin film evaporation and isolation of amorphous materials.
- Ability to use modelling software (e.g. Aspen, DynoChem, Computational Fluid Dynamics) to support process understanding.
- Experience working with CMOs.
- Experience in leading technical projects or act as a lead process engineer on the projects.
AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
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. Always committed to lifelong learning, growth, and development.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Please include your CV, ensuring that you include the subjects and grades of any qualifications achieved.
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.