Scientist – Analytical Science Early Product Development and Manufacture, P

at  AstraZeneca

ACCOUNTABILITIES

• Development and validation of robust analytical methodologies supporting the development of innovative drug products.
• Planning and conducting lab-based experimental work to meet project timelines and support the overall portfolio.
• Providing technical support to the manufacture of investigational medicinal products for clinical use.
• Interpreting analytical data and drawing reliable conclusions and recommendations to guide/influence future work.
• Understanding the CMC contributions to regulatory filings and aid preparation of successful responses to questions.
• Identifying and tackling analytical project issues.
• Identify and work to make improvements in analytical ways of working.
• Working as a member of cross-functional teams, representing EPDM.
• 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 SKILLS/EXPERIENCE

• BSc, MSc or equivalent in a relevant subject area
• Knowledge of the key analytical techniques for the analysis and characterization of oral solid formulations
• An understanding of the principles and management of SHE and cGMP
• Strong lab practical skills
• 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 prioritization skills to ensure project delivery
• Good communication and partnering skills, able to discuss sophisticated 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

DESIRABLE SKILLS/EXPERIENCE

• A good understanding of the drug development process from discovery to launch
• Experience of supporting clinical manufacture and working with Contract Manufacturing Organisations (CMOs)
• Experience of authoring, or contribution to the CMC content for the analytical aspects of drug product regulatory filings within the early phase
  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. This is a lab based role so will be lab based five days per week, 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.
  Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way. We’re investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success. Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.
  Ready to make a difference? Apply now!
  We welcome your application before the 8th November.

We are seeking a highly motivated Analytical Development Scientist to join our dynamic Early Product Development and Manufacture (EPDM) teams in Macclesfield. In this lab-based role, you will be responsible for developing analytical knowledge that supports the development, design & manufacture of solid oral drug products. Your contributions will be essential in delivering analytical method development, validation, and testing to advance project timelines for small molecule drug products in the early clinical phases. Additionally, you will work in a fast-paced environment and play a key role in supporting the portfolio, not just your own project.