AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical and the supply of healthcare services. But we’re more than one of the world’s leading pharmaceutical companies! At AstraZeneca, we're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express different perspectives and are made to feel valued, energised and rewarded for their ideas and creativity.

In Pharmaceutical Technology and Development (PT&D), we are the link between forward‐thinking science and innovative Medicines that help millions of patients. 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.

We are currently looking for an Analytical Scientist in New Modalities and Parenteral Development(NMPD).

Within NMPD our vision is to transform product design and development to enable us to deliver medicines to patients. You will join a vibrant team that is working on the next generation of medicines and play a key role in the analytical development of new medicinal products. Our vision is to transform product design and development to enable us to deliver New Modality and Parenteral Medicines to Patients. New Modalities is a key growth area for AstraZeneca, covering projects that are not standard small molecule formulations/products. New Modalities can include Peptides, Oligonucleotides, Nano Medicines, Polymeric nanoparticles and Dendrimer and Polymer Drug Conjugates.

What you'll do

You will be responsible for delivering analytical knowledge that encompasses understanding of

manufacturing processes, control strategy and robustness. You will work cross functionally with multiple internal and external interfaces, supporting drug projects from the early clinical phase through to commercial filings. This is your opportunity to deliver medicines that have a direct impact on patients’ lives!

Key Accountabilities:

• Development and validation of robust analytical methodologies supporting the development of innovative drug products and manufacturing processes
• Planning and conducting lab‐based experimental work to meet project timelines
• Interpreting analytical data and drawing reliable conclusions and recommendations to influence future work
• Delivering CMC content or contributions to regulatory filings and preparation of successful query responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH,EMEA, FDA) and other territorial requirements
• Identifying and tackling analytical project issues
• Applying technical knowledge to improvement projects and the evaluation of new technology/processes
• Working as a member of cross‐functional teams, representing own department or area of expertise
• Keeping a strong focus on quality for our patients by ensuring that work is performed in accordance with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Manufacturing Practice (GMP)

Essential Requirements:

• BSc, MSc or equivalent in a relevant subject area
• Knowledge of the key analytical techniques for the analysis and characterisation of drug products
• An understanding of the principles and management of SHE and cGMP

Desirable

• Knowledge of, and practical skills, in oligonucleotide and peptide analysis across a range of techniques particularly LC and MS
• A good understanding of the drug development process from discovery through to launch
• Experience of supporting clinical manufacture and working with contract manufacturing organisations
• Experience of authoring CMC content for the analytical aspects of drug product regulatory filings throughout the clinical development phase

Skills and Capabilities

• Solid understanding and experience in pharmaceutical analysis across a range of techniques
• Knowledge of, and practical experience, of quality and regulatory requirements (e.g. GMP and ICH), technology transfers and method validation
• Ability to think and operate across boundaries, challenge the status quo and seek opportunities for business improvement
• Effective influencing and prioritisation skills to ensure project delivery
• Good communication and partnering skills, able to discuss complex ideas in a simple, easy to understand manner
• Collaborative work ethic with the ability to work internally and externally across a wide range of partners

Interested? Come and join our journey.

So, what’s next!

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

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.