Associate Principal Scientist – CMC Project Expert (Analytical)

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

Macclesfield (UK)

Date opens: 28/11/2023

Date closing: 07/01/2024

We are currently recruiting for an experienced CMC Project Expert to join our expanding analytical group within Chemical Development, we are looking for a motivated individual to lead essential analytical activities for the successful delivery of late-phase clinical and commercial API (active pharmaceutical ingredient) across our small molecule portfolio.

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.

Chemical Development:

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 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.

Key responsibilities:

As an experienced project expert in the analytical skill area, you will be responsible for providing strategic and technical leadership for successful development of our Active Pharmaceutical Ingredients (APIs). You will work collaboratively with a multiskilled team including process chemists, engineers, project managers, quality assurance, supply chain and external partners to define the regulatory control strategy and ensure medicines to patients.

Including but not limited to;

  • Leading complex development projects, from phase 2b/3 to commercial within analytical skill area,
  • Defining project control strategies throughout the development phases of the project.
  • Provide scientific/technical and strategic leadership across the skill groups in resolving risks, whilst identifying learning to share across the department,
  • Deliver CMC content or contributions to regulatory filings throughout the clinical development phase and commercial filings,
  • Coaching and developing colleagues, supporting them in reaching their full potential.
  • Identifying and solving potential issues and acting as an interface between departments.
  • Provide expert challenge to drug projects and role model positive behaviours in exploring new ways of working and scientific development,
  • Contributing to the analytical strategy within Chemical Development enabling project delivery, supporting the current and future project portfolio.

Essential skills and experience:

  • BSc/PhD level education in a relevant field and a significant number of years’ experience working within a Research, Development and Manufacturing environment within the pharmaceutical industry,
  • Experience of technical supervision, coaching and mentoring or leading small teams of people or significant scientific projects,
  • A thorough understanding of key analytical techniques, including NMR, chromatography, and mass spectrometry,
  • Experience in management of complex projects (including resourcing, risks, and stakeholder management),
  • Experience in building the regulatory control strategy for API or drug products,
  • Experience in supporting clinical and/or commercial manufacture and/or working with contract manufacturing organisations,
  • Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement,
  • A thorough appreciation of the principles and management of Safety, Health and Environment (SHE) and Good Manufacturing Practice (cGMP).

Desirable skills and experience:

  • A good understanding of the overall drug development process from discovery through to launch,
  • Experience in delivering CMC content or contributions to regulatory filings for clinical and commercial products,
  • Excellent communication and strategic influencing skills across interfaces of discipline, culture, and expertise both internally and externally,
  • The ability to lead improvement projects confidently and successfully,
  • Ability to analyse and interpret complex situations and provide clear strategic direction.

How to Apply

To be considered for this exciting opportunity, please complete the full application form on our website. Please note, applications must include your current CV and a covering letter, which present the opportunity for you to share your motivation for applying, as well as suitability for the role.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.

Why AstraZeneca?

At AstraZeneca, we 're dedicated to being an outstanding Place to Work. Where you are empowered to push the boundaries of science and spark your high-reaching spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and partnership, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

Are you ready to bring new insights and fresh thinking to the table, Brilliant! We have one seat available, and we hope it’s yours.

Competitive salary and benefits.

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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