Senior Scientists – Analytical in Global Product Development
Location: Cheshire East
Job Type: Full time
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse 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 bridge between forward-thinking science and innovative 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.
We are currently looking for a Senior Scientist – Analytical Science in Oral Product Development Macclesfield (OPD). Our vision is to transform product design and development to enable us to deliver new medicines to patients. Oral products are key growth areas for AstraZeneca, covering a wide range of projects including small molecule immediate release as well as modified release and complex formulations.
You will join a vibrant team that is working on the next generation of medicines and playing a key role in the analytical development of new medicinal products. Bring your experience in the areas of pharmaceutical analysis and your strong analytical perspective to the team and be a leader in the late stage development of new drug products.
You will deliver analytical knowledge that encompasses understanding of manufacturing processes, control strategy, robustness and stability. You will also work cross functionally with multiple internal and external interfaces, supporting drug projects from the early clinical phase through to commercial filings.
- Support project progression during clinical development phases through to commercialisation, by delivering analytical testing for clinical release as well as stability studies to GMP standards.
- Interpret analytical data and draw reliable conclusions and recommendations to influence future work
- Identify and solve analytical method issues.
- Prioritise, plan and execute experimental work in accordance with project timelines.
- Coach and support the development of more junior staff
- Demonstrate scientific leadership to facilitate strategic development of drug projects and technical development of other scientists.
- Shape analytical strategy in collaboration with key partners within and external to the department.
- Deliver CMC content or contributions to regulatory filings and preparation of successful responses to questions; applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements.
- BSc, MSc or equivalent in a relevant subject area with a proven track record in the pharmaceutical environment or a PhD with significant experience.
- A strong understanding of key analytical techniques for the analysis and characterisation of drug products.
- Experienced with working to cGMP standards.
- Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.
- Experience of characterising and developing analytical methods.
- Experience of leading technical contribution of a scientific programme, both independently and alongside partners.
- An understanding of the principles and management of Safety, Health & Environment (SHE).
- A good understanding of the overall drug development process from discovery through to launch.
- Experience of supporting clinical manufacture and working with contract manufacturing organisations.
- Experience in the development of control strategies
- Experience of authoring CMC content for the analytical aspects of drug product regulatory filings throughout the clinical development phase.
- Experience of delivering the analytical contribution to development pharmaceutical products
- Knowledge and experience of technology transfers and method validation.
Skills and capabilities
- Knowledge of and practical skills in pharmaceutical analysis across a range of techniques.
- Expertise in the characterisation and development of analytical methods.
- Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of utilising risk based approaches for successful delivery.
- 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 partner 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.
- Excellent problem solving skills.
Please note applications must include your CV and a covering letter which presents your areas of strength / development and why you should be considered for the role.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together.
Closing date: February 8th 2023
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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.