Associate Principal Scientist – Predictive Stability, Oral Product Development

Macclesfield, UK

Introduction to Role:

Join us at AstraZeneca in our Pharmaceutical Technology and Development (PT&D) department, where we bridge the gap between innovative science and life-changing medicines. We are currently seeking an Associate Principal Scientist – Predictive Stability in Oral Product Development Macclesfield (OPD). This role is a key growth area for AstraZeneca, and your contributions will facilitate the wider goals of the department and function. You will lead a technical specialism that impacts drug projects across the portfolio, at all stages of development and the on-market space.

Accountabilities:

In this role, you will be responsible for the global expansion of the technical area across sites and functions. You will define and deliver the strategy direction of the group, ensuring alignment to analytical sciences and wider business strategies. You will also be accountable for the development, maintenance, and delivery of the Predictive Stability strategy for AstraZeneca at a departmental level.

Essential Skills/Experience:

- BSc, MSc or equivalent in a relevant subject area with a proven track record in the pharmaceutical environment or a PhD with significant experience.

- Experience in designing, deploying and leading strategic initiatives around stability.

- Connections in academia to facilitate the technical development of the Predictive Stability field.

- Experience in the application of Predictive Stability elements/outputs in the development of product control strategies.

- A strong understanding of key analytical techniques for the analysis and characterisation of drug products during Predictive Stability studies.

- Experience of supporting clinical manufacture and working with contract manufacturing organisations on the delivery of Stability Studies.

- Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.

- An understanding of the principles and management of Safety, Health & Environment.

- 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 and strategic 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.

Desirable Skills/Experience:

- A good understanding of the overall drug development process from discovery through to launch.

- Experience of authoring dedicated Predictive Stability elements of Marketing Applications.

- External industry presence in the field of Predictive Stability, including external conferences and working groups.

- Experience in representing a technical area at a functional level, including conveying capital and resource requirements for the area.

- Experience of authoring CMC content for the analytical aspects of drug product regulatory filings.

- Knowledge and experience of analytical technology transfers.

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. That’s why we work, on average, a minimum of three days per week from the office. 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.

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.

Why AstraZeneca?

At AstraZeneca, we are leading our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. We are the champions of Lean, ensuring our teams understand and embody the benefits it can bring. There's improved quality and safety, as well as speed. Our manufacturing sites are environments of constant and rapid change. It's a place to expect the unexpected. There's rarely an obvious answer to the varied challenges we face, so it takes adaptability, flexibility and patience to thrive here.

Ready to make a difference? Apply today and join us in our mission to deliver life-changing medicines!

Date Posted

22-lut-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.