Principal Scientist – CMC Project Expert (Analytical)

AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Principal Scientist – CMC Project Expert (Analytical)

Macclesfield UK

Do you have expertise in, and passion for chemical development, would you like to apply your expertise to impact the analytical science in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, innovation-driven biopharmaceutical company, where we not only focus on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. We believe in sustainability and are determined to minimise the impact of our work on the environment.

We are more than one of the world’s leading pharmaceutical companies. We are proud to be a great place to work and have a culture that inspires innovation and collaboration. We empower our colleagues to be their authentic selves, express diverse perspectives and at the same time feel valued, respected and rewarded for their ideas and creativity.

Pharmaceutical Technology & Development:

Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into 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.

In Chemical Development we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to our patients. Focussed on later stage (Phase 2/3) and commercial active pharmaceutical ingredient (API’s) projects, we combine technical knowledge and understanding with individual talent to define the commercial control strategy, drive design, development, and optimisation of synthetic routes and analytical methodologies that deliver medicines in a sustainable, commercially viable way. Chemical development delivers innovation and continuous improvement, working closely with colleagues in academia and across industry, to ensure that we apply the newest technologies and principles in the development and delivery of our medicines.

We now have an exciting opportunity for a Principal Scientist, Analytical Project Specialist in our growing analytical science skill group. Analytical Science is fundamental to what we do in Chemical Development, therefore maintaining and developing cutting-edge expertise in analytical science underpins our ability to delivery robust and sustainable commercial manufacturing processes. As a specialist in Analytical Science with a consistent track record of delivering innovative solutions to diverse problems, in a pharmaceutical development environment, you will be responsible for ensuring the development of our analytical strategy and capability, providing expert support to delivering robust control strategies, methodologies and data to regulatory submissions for small molecule APIs.

Accountabilities/Responsibilities:

The role holder is responsible for developing and improving analytical project capability across Chemical Development:

  • Enable the right analytical understanding to be generated across all aspects of drug substance Route Design, Process design and lifecycle management.

  • Provide scientific leadership and mentoring to multi-disciplinary teams of chemists, analysts, process engineers and specialists to develop robust commercial enhanced control strategies and analytical methods.

  • Assure approvable regulatory submission packages (both clinical and marketing)

  • Enhance the analytical research and development capability across the Chemical Development department.

  • Define and prioritise strategic improvement programmes, along with mechanisms to secure resources.

  • To assure we maintain and optimise supply for AstraZeneca commercial products meeting cost and quality targets for our customers.

The role includes:

  • Understanding the project portfolio and the analytical science requirements and challenges across the portfolio.

  • Create, prioritise and drive the identification, investigation and implementation of  solutions to these challenges across the department (including at the boundary with Drug product and other departments).

  • Driving knowledge and deployment of core analytical skills into AZ Drug Projects.

  • Developing new & innovative science and technology beyond our current capability to tackle future projects.

  • Acting as a reference to drug project teams and facilitate early support/advice/coaching from across Chemical Development

  • Provide advice to project teams to ensure scientific rigor in analytical development activities.

  • Driving practices and sharing of learning across Science Units

  • Implementing an Analytical Science strategy through PT&D

  • Developing strategic internal and external collaborations as appropriate

  • Representing AZ on external science and regulatory bodies

  • Enhancing AZ external reputation externally through patents, publications, lectures and guiding.

  • Provision of experienced consultation of Analytical Science with other partner functions

  • Enhancing the capability of Chemical Development in development project delivery.

  • Proactively providing scientific contribution which impacts development projects across all clinical and commercial phases of development.

  • Represent Chemical Development on other AZ global analytical science networks outside PT&D as appropriate to define the scope of activities that has an impact on AZ drug portfolio

All these activities will have a significant impact on the speed, quality and cost of the AZ development and commercial portfolio. The role, therefore, has a significant impact on both financial and reputational aspects of the business.

Essential Skills & Capabilities

  • BSc/PhD level education in a relevant Analytical science field and a significant number of years of experience working within a Research & Development or Manufacturing environment, within the pharmaceutical industry

  • Will have broad analytical and project development knowledge

  • Ability to develop a broad network across the PT&D organisation and wider operations/R&D.

  • Will require significant experience of leading large-scale project/change work

  • Requires a thorough understanding of the principles and management of SHE and cGMP

  • Requires an extensive understanding of regulatory requirements, submissions and strategies across all clinical and commercial phases.

  • Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement

  • Ability to analyse and interpret sophisticated situations and provide clear strategic directions for others

  • Excellent communication and strategic influencing skills across interfaces of subject area, culture, and expertise both internally and externally

  • Excellent team working and networking skills and encourages team effectiveness.

  • Strong leadership skills possibly leading large project teams

  • Experience and skilled at facilitation at all levels

  • Validated problem solver with in depth analytical skills

  • Change management and project management skills

  • Demonstrate a high degree of credibility and end to end supply chain thinking

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Competitive Salary and benefit package

The site provides a collaborative environment where everyone feels comfortable and able to be themselves which is at the core of AstraZeneca’s priorities

Where can I find out more? Our Social Media, Follow AstraZeneca on

  • LinkedIn https://www.linkedin.com/company/1603/
  • Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
  • Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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.

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