Jobs / Sweden / Astrazeneca Pharmaceuticals Lp
Analytical Project Senior Scientist Pharmaceutical Development
Astrazeneca Pharmaceuticals Lp · 🌍 Sweden - Gothenburg
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About the role
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 analyt