Scientist – Analytical Science Early Product Development and Manufacture, Pharmaceutical Sciences
Location: Macclesfield, UK
Do you have a desire to work in drug product development? Are you passionate about analytical science, and can you envision applying your expertise to positively impact the development of new medicines? Join us to push the boundaries of science!
Pharmaceutical Sciences is a Chemistry Manufacturing and Controls organisation working in the Early Portfolio and is accountable for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities, across the whole range of AstraZeneca’s therapeutic areas.
What you'll do
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.
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.
Ready to make a difference? Apply now!
We welcome your application before the 8th November.
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