Analytical Project Senior Scientist Pharmaceutical Development

Job description

Are you ready to shape the future of medicines—pioneering technical and scientific breakthroughs that transform patient lives? Are you passionate about converging your analytical science experience and leadership skills? Then this role might be the right one for you! Pharmaceutical Technology and Development (PT&D) sits within AstraZeneca Operations and is the organization that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AstraZeneca’s commercial drug substances and products to ensure we successfully supply medicines to patients. We are seeking an experienced and innovative Analytical Project Senior Scientist with the potential to be a skill lead for analytical activities in global product development (GPD). Our vision is to transform product design, development and characterization to enable us to deliver new medicines to patients. In this role, you will develop analytical methods and strategies for oral solid dosage forms and/or inhaled products from early development through clinical supply and toward commercialization. Acting as a project scientist/skill lead for analytical, you will partner across formulation, device engineering, biopharmaceutics, manufacturing, QA and Regulatory to deliver robust methods, efficient control strategies, and regulatory submission ready documentation. What you will do We are looking for you who combines robust knowledge in pharmaceutical development and strong analytical background with critical thinking to generate decisive 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. This is a lab-based role. Responsibilities include, but will not be limited to: Method development & validation : Design, develop, validate and transfer analytical methods (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, including stability indicating methods) and specification setting. Characterisation & performance : Lead drug product characterization and stability programs. Cross functional collaboration : Work closely with formulators, device engineers, aerosol scientists, manufacturing sites and external partners/CMOs to integrate analytical deliverables into project plans. Problem solving : Lead complex investigations, root cause analyses and data integrity assessments; drive timely resolution and preventive actions. Ways of working & innovation : Enable learning between projects, and lead science/technology initiatives including patenting and/or publishing. Quality & governance : Ensure GxP compliance where applicable, data integrity, rigorous study design and clear communication to governance bodies. CMC & regulatory : 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. Analytical strategy & control : Develop the analytical control strategy aligned with ICH guidelines across clinical phases. Technical supervision & coaching : Provide scientific, regulatory and technical supervision; mentor and coach colleagues to enable project objectives and build capability. Essential requirements MSc or PhD or equivalent experience in a relevant scientific subject area (Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or related). Experience of analytical development work and CMC deliveries across projects. Experience working in GMP environments and corresponding instrument/equipment maintenance procedures. Practical experience with data and workflow tools used in analytical development (e.g., ELN/CDS, statistical software such as JMP/Minitab, and basic scripting in Python/R for data wrangling, visualization, and predictive model deployment). Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution and/or aerosol characterization techniques used for inhaled product (such as impactor analysis) and complementary methodologies for small and/or large molecules. Experience in method development (including use of supporting software), validation, transfer and lifecycle management under ICH guidelines and phase appropriate frameworks. Experience evaluating stability data and assigning shelf life to drug products. Experience authoring CMC analytical content and responding to regulatory queries across clinical development. Demonstrated business and digital acumen, including: Comfort working with data-rich environments and using digital tools to enhance scientific insight and decision-making. The ability to engage with emerging AI-enabled, automation, or advanced analytics approaches and translate them into practical, compliant applications within analytical development. A curious approach towards new technologies, with the judgement to balance innovation, scientific rigor, and regulatory expectations. Proficiency in English, oral and written. Excellent communication, stakeholder management and influencing skills Desired requirements Demonstrated ability to troubleshoot technical challenges and drive data driven decisions. Experience of advanced structured problem-solving techniques e.g. six sigma 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 (e.g., regression, ANOVA, capability/variation analysis, stability trending, OOS/OOT investigation). Experience with statistical analysis tools (e.g., Minitab) and DoE for method development, data evaluation and acceptance criteria. 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). For inhalation: advanced performance assessment techniques and aerosol characterisation; for oral products: solid-state characterisation (e.g., XRPD, DSC, TGA) and dissolution strategy. Experience supporting clinical manufacture and working with CMOs, including method transfer and comparability. Experience of leading teams and/or scientific projects within a global organization and with external partners. Experience acting as project lead/skill lead and influencing cross functional strategies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. We welcome your application no later than 16th October 2026 ! Please tailor your application for this role! Date Posted 02-okt.-2026 Closing Date 15-okt.-2026 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.