Senior Scientist – Analytical Lead

AstraZeneca; Macclesfield; On-site; GBP 85,000 - 110,000; Full time

Job summary

AstraZeneca Macclesfield seeks an experienced Analytical Lead to shape and deploy analytical control strategies across drug development. You will design, validate and transfer analytical methods (HPLC/UPLC, LC–MS), lead stability programs and author CMC content for IND/MAA submissions, while collaborating with cross-functional teams to ensure regulatory success.

Strong data analytics, DoE, and statistical tool proficiency are essential, as is the ability to mentor colleagues and drive continuous

Qualifications

• MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences or related field.
• Experience in pharmaceutical analytical science with regulatory CMC knowledge.
• Strong chromatography experience (HPLC/UPLC, LC–MS) and dissolution methodologies.
• Excellent communication and cross-functional collaboration skills.
• Ability to drive data-driven decisions and troubleshoot issues.
• Fundamental digital data capabilities and DoE concepts.

Responsibilities

• Lead analytical control strategy development and lifecycle management.
• Define end-to-end analytical strategies across clinical phases.
• Design/validate/transfer analytical methods (HPLC/UPLC, LC–MS).
• Lead stability programmes and inform formulation choices.
• Author CMC analytical content for regulatory submissions and responses.
• Collaborate with formulators, engineers, and manufacturing for tech transfers.
• Lead investigations and ensure data integrity and GxP compliance.
• Apply multivariate design and DoE for method development and analytics.
• Provide governance and mentorship within the analytical team.

Skills

Analytical leadership

Regulatory interaction

Data-driven decision making

Stakeholder management

Troubleshooting

Education

MSc/PhD in Analytical Chemistry or related

Tools

HPLC/UPLC

LC-MS

ELN/CDS

JMP

Minitab

Python/R (basic)

Job description

Introduction to role:

Are you ready to lead analytical control strategies that accelerate medicines from lab to clinic and beyond? Based in Macclesfield, you will shape how we design, validate and deploy analytical methods that directly determine product robustness, speed to patients and regulatory success.

Accountabilities:

• Analytical Leadership: Act as the analytical skill lead to secure major drug product deliveries, applying a risk-based, flexible approach to prioritisation and timelines, ensuring focus on the highest-value outcomes.
• Control Strategy Ownership: Define and lead an end-to-end analytical control strategy aligned with CMC guidelines across clinical phases, delivering robust, efficient controls that de-risk programmes and enable confident regulatory interactions.
• Method Development and Lifecycle: Design, develop, validate and transfer analytical methods (HPLC/UPLC, LC–MS, dissolution, impurity profiling), establishing stability-indicating performance and ensuring reproducibility across internal sites and CMOs.
• Product Characterisation and Stability: Lead drug product characterisation and stability programmes to inform formulation choices, specifications, shelf-life and critical quality attribute understanding, translating data into decisive action.
• Regulatory Authoring and Interaction: Author analytical CMC content for IND/IMPD/NDA/MAA, validation reports, method transfers and specifications; anticipate and respond to regulatory queries with clear, evidence-based narratives.
• Cross-Functional Integration: Embed analytical deliverables into project plans with formulators, engineers, manufacturing and external partners; enable seamless tech transfer and scale-up with clear communication to governance bodies.
• Investigation Excellence and Data Integrity: Lead investigations, root cause analyses and data integrity assessments; drive timely corrective and preventive actions and ensure GxP compliance with rigorous study design.
• Digital and Predictive Enablement: Apply modern data analytics, multivariate design and DoE to accelerate method development; champion the practical use of ELN/CDS and statistical tools to make data-driven decisions visible and reusable.
• Progression and Impact: Deliver immediate analytical milestones while shaping best practices, mentoring colleagues and contributing to continuous improvement that supports faster, more sustainable delivery of medicines.

Essential Skills/Experience:

• MSc or PhD or equivalent experience in a relevant scientific subject area (Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or related).
• 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.
• Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and complementary methodologies for small and/or large molecules.
• 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.

Desirable Skills/Experience:

• 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.

Why AstraZeneca:

Here, science meets focused execution in a collaborative environment where unexpected teams come together to unlock bold thinking. You will work hands‑on with cutting‑edge analytical technologies and digital tools, translating complex pipelines into reliable medicines for larger patient populations. We value kindness alongside ambition, giving you the support to lead while you learn, and the freedom to take ownership of outcomes. Our in‑person culture brings pace and clarity to complex decisions; we typically work predominately on site while balancing individual flexibility. Your contribution also extends to our sustainability ambition, with tangible opportunities to help reduce our environmental footprint as we advance toward zero carbon operations and a carbon negative value chain—linking your daily decisions in the lab to a healthier future for patients, communities and the planet.

Our 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.