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Drug Substance Analytical Project Expert

AstraZeneca UK

Location: Cheshire East

Job Type: Full time


Role Name: Drug Substance Analytical Project Expert

Location: Macclesfield, UK

Competitive Benefit & Salary

Do you have expertise in, and passion for drug substance 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 delivery of life-saving medicines to our patients but believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a great place to work and have a culture that encourages innovation and teamwork. 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, crafting and delivering active pharmaceutical ingredients (API’s), 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.

Drug Substance Development:

In Chemical Development we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to patients. Focussed on late stage (Phase 2/3) and commercial drug substance, 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 balanced, commercially viable way. As a department delivering scientific excellence, we are focussed on innovation, continuous improvement, sustainability, automation, and lifelong learning.

The department and analytical area are growing, AstraZeneca are recruiting highly experienced project leaders to lead multiple or sophisticated projects in our small molecule, new modalities, and commercial drug substance teams, defining and ensuring the next generation of medicines.

Key responsibilities:

  • As an expert project lead, you will bring a depth of late phase experience to development and commercial control strategy understanding to navigate drug substance manufacture, clinical and commercial supply demands, whilst developing and implementing control strategies that are deliverable in the clinical and commercial environment

  • You will work independently leading interactions and stakeholder management across project management, quality and regulatory departments ensuring success in CMC project delivery. You are expected to drive continuous improvement by always seeking to optimise our current ways of working or through developing innovative approaches to project delivery

  • You will contribute to the department ambition of supporting and growing careers in science by leading successful initiatives that include driving forums for shared learning, as well as mentoring and developing scientists across analytical within chemical development

Specifically, this includes:

  • Leading complex large or small molecule projects, late phase (2b/3) to commercial within analytical skill area

  • Delivering control strategies throughout the development and post approval phases of projects.

  • React to changes in the regulatory environment, supporting and implementing changes within the business.

  • 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, managing updates, change control and post approval changes.

  • 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, leading strategic improvements for project delivery, supporting the current and future project portfolio

Crucial skills and experience:

  • BSc/PhD level education in a relevant subject area 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 chromatography.

  • Experience in leading sophisticated projects (including handling resourcing, risks, and stakeholders).

  • Experience in building the regulatory control strategy for drug substance 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 broad understanding of the overall drug development process from discovery through to launch in either small molecule or new modalities.

  • Experience in delivering CMC content or contributions to regulatory filings for clinical and commercial drug substance.

  • Excellent communication and strategic influencing skills across interfaces of field, 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.

Date Posted


Closing Date

07-Apr-2024Our 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.
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