Senior Director - Small Molecule Analytical Science in Chemical Development in Macclesfield

We are seeking a highly skilled and motivated leader to join the Analytical function in AstraZeneca's Chemical Development department. The successful candidate will be responsible for leading a section of the Analytical function developing control strategies for drug substance manufacturing processes and supporting regulatory documentation. The Senior Director will work closely with the Function Head for Analytical to deliver the Small Molecule development strategy and drive successful delivery of the project portfolio through Phase 3-enabling clinical development to commercialisation.

Are you ready to lead small molecule analytical science that supports the transformation of complex synthetic routes into robust manufacturing processes with control strategies for patients who need them? This is a high-leverage leadership position where your decisions and standards will accelerate how our portfolio moves from molecule to medicine with speed, reliability, and affordability. Do you excel in a fast-paced, highly collaborative setting where curiosity meets rigour to deliver meaningful impact? Join us to shape enterprise-wide strategy, develop high-performing leaders, and embed modern ways of working that elevate performance across teams, sites and external partners. You'll influence at the intersections-connecting strategy to execution, people to purpose, and data to decisions-to unlock measurable results and sustained growth.

At AstraZeneca, we are united by a bold ambition: to push the boundaries of science and deliver life-changing medicines to patients worldwide. As a global, science-led biopharmaceutical company, we transform pioneering research into breakthrough treatments across oncology, cardiovascular, respiratory, and rare diseases. Here, your talent will contribute to innovations that truly matter—helping us reimagine healthcare and create a healthier future for all!

Responsibilities

• Lead a section of Analytical team leaders (and associated teams) and senior scientific staff to drive technical excellence in delivery of the analytical contribution to small molecule drug substance projects, with accountability across:

• Route design, process design and optimisation, process characterisation and validation, leading to commercial control strategy development
• Technology transfer and support of clinical drug substance manufacture and process validation
• Release processes for clinical batches of drug substance
• Stability strategies for drug substances
• Broad knowledge and application of ICH guidance in drug development
• Delivery of CMC regulatory submissions for clinical and marketing - acting as reviewer and approver

• Coaching and mentoring to support professional development as leaders, including onboarding of first-time team leaders
• Advanced performance management - goal setting and regular feed-forward to drive high impact contributions
• Driving SHE and Quality compliance across an organisation

Role scope includes responsibility for developing control strategies for drug substance manufacturing processes and supporting regulatory documentation, and delivering the Small Molecule development strategy and project portfolio through Phase 3 to commercialisation.

Qualifications

• Degree in Analytical Science or Chemistry + a minimum of 10 years' experience in pharmaceutical development
• Proven high impact people leadership experience, with a track record of effectively managing and developing scientific teams through coaching and mentoring. Demonstrated experience of leading senior staff - either scientific or team leaders is highly desirable
• Expert in development of Analytical methodologies to control and characterise drug substance from commercial manufacturing processes, including advanced understanding of the contribution of chemistry, chemical engineering, and particle science
• Strong understanding of the drug development processes, especially late-stage development to support Phase 3 clinical studies and launch
• Proven experience in authoring and reviewing clinical and marketing regulatory submissions

Desirable Skills/Experience:

• Track record of driving the introduction of digital approaches and new analytical technology is highly desirable
• Strong project management skills and the ability to drive multiple projects simultaneously within the team
• Demonstrated experience of inspiring change and continuous improvement to improve efficiency with measurable impact