Associate Principal Scientist – Analytical Project Lead Full-time NEW

Associate Principal Scientist – Analytical Project Lead Macclesfield, UK

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It's inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people's lives better – from patients and their families to all of us in society.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

We are seeking an experienced and innovative Analytical Project Lead in Global Product Development (GPD) with an in depth knowledge of separation science and chromatographic method development. Our vision is to transform product design, development and characterisation to enable us to deliver new medicines to patients. In this role, you will lead analytical strategy and delivery for oral solid dosage forms and/or parenteral products from early development through clinical supply and toward commercialisation. Acting as a project lead/skill lead for analytical, you will partner across formulation, engineering, biopharmaceutics, manufacturing, QA and Regulatory to deliver robust methods, efficient control strategies, and regulatory submission ready documentation. Experience with modern data analytics and predictive tools to accelerate analytical development is critical.

We are looking for you who combines a robust knowledge (or experience) in pharmaceutical development and strong analytical background with critical thinking to generate data and control strategies. You are comfortable in aligning stakeholders, set direction and resolve ambiguity to keep programs on track and meet milestones. We see that you enjoy driving learning between projects and thrive in introducing new technologies and ways of working.

Key Responsibilities:

• Act as analytical skill lead to secure major drug product deliveries, applying a risk based, flexible approach to prioritisation and timelines.
• Define and lead the analytical control strategy aligned with CMC guidelines across clinical phases.
• Design, develop, validate and transfer analytical methods (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, including stability indicating methods)
• Lead drug product characterisation and stability programs.
• Author/review analytical CMC content for IND/IMPD/NDA/MAA, as well as validation reports, method transfer documents, specifications, responses to regulatory queries and other CMC and regulatory documents.
• Work closely with formulators, engineers, manufacturing sites and external partners/CMOs to integrate analytical deliverables into project plans.
• Provide scientific, regulatory and technical supervision; mentor and coach colleagues to enable project objectives and build capability.
• Lead investigations, root cause analyses and data integrity assessments; drive timely resolution and preventive actions.
• Ensure GxP compliance where applicable, data integrity, rigorous study design and clear communication to governance bodies.

Requirements:

• MSc or PhD or equivalent experience in a relevant scientific subject area (Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or related).
• Significant experience in pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications and experience authoring CMC analytical content and responding to regulatory queries.
• Record of leading teams and/or scientific projects within a global organization and with external partners.
• Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and complementary methodologies for small and/or large molecules.
• Applied chromatographic leadership: Independently design and implement phase appropriate HPLC/UPLC methods for drug products and substances, selecting orthogonal approaches when needed, establishing scientifically justified system suitability and specifications, leading robustness and method suitability assessments, directing fit for purpose sample preparation strategies, resolving critical separation issues and ensuring reliable method transfer/readiness for GMP execution with clear documentation and analyst guidance.
• Excellent communication, stakeholder management and influencing skills; ability to operate confidently and collaboratively across global, cross skill environments.
• Demonstrated ability to troubleshoot technical challenges and drive data driven decisions.
• Fundamental digital and data capability relevant to analytical development, including: proficiency with multivariate experimental design and basic DoE concepts for method and process understanding.
• Working knowledge of statistics for analytical science and practical use of common data and workflow tools (e.g., ELN/CDS, and statistical software such as JMP or Minitab) for data analysis and reporting.

Desirables:

• Strategic chromatographic and separation science leadership: Define orthogonal method suites (RP, HILIC, ion exchange, SEC, SFC, CE) to secure impurity resolution and stability indicating capability; use multidimensional LC and targeted DoE to speed development and set robust specifications; harmonise methods across sites with clear comparability criteria; embed lifecycle management and coach teams through complex separations for peptides, oligonucleotides, and challenging matrices, including forced degradation studies.
• Experience applying advanced predictive analytics beyond foundational skills (e.g., Bayesian optimisation for robustness tuning, Chemometrics for pattern recognition, mechanistic/hybrid models for dissolution or degradation kinetics, advanced statistical methods for specification setting and uncertainty quantification).
• Practical experience with basic scripting in Python/R for data wrangling, visualisation, and deployment of predictive models in an analytical context.

In Office Requirement:

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 five 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.

Competitive salary and benefits package on offer!

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.