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Senior Scientist– Predictive Stability, Pharmaceutical Product Development

AstraZeneca PLC
10 hours ago
Full-time
On-site
Sweden - Gothenburg
Clinical Research and Development
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. If you are swift to action, willing to collaborate, and curious about what science can do, don't hesitate to apply! We are currently looking for a Senior Scientist in Predictive Stability in Global Product Development (GPD) in Gothenburg. Pharmaceutical Technology and Development (PT&D), sits within Operations, and is the organisation that bridge between brilliant science and innovative medicines that help millions of people. We work across the entire value chain, designing and delivering the active ingredients, formulations and combination products required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. As a Senior Scientist in Predictive Stability in GPD you will operate across a technical specialism that impacts drug projects portfolio‑wide, from early development to on‑market, and you will be instrumental in expanding this capability globally across sites and functions. You will also play a key role in delivering the group’s strategic direction, ensuring alignment with Analytical Development and broader business strategies. Key accountabilities: Design and evaluate Accelerated Predictive Stability (APS) studies for drug products across modalities and dosage forms, using appropriate predictive modelling tools. Develop stability strategies for drug products in collaboration with the drug product projects. Deliver Predictive Stability CMC technical content for contribution to regulatory filings and preparation of successful responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements. Demonstrate scientific guidance to facilitate strategic development of drug projects and technical development of other scientists. Interpret analytical data and draw reliable conclusions and recommendations to influence future work. Coach and support the development of more junior staff. Apply data science tools, including AI/ machine learning (ML), to advance analytical interpretation and data flow. Essential Requirements: BSc, MSc or equivalent in a relevant subject area with a proven track record in the pharmaceutical environment or a PhD with significant experience. Experience in designing, deploying and leading strategic initiatives around drug product stability. Experience in the application of Predictive Stability modelling in the development of product control strategies. A strong understanding of stability indicating critical quality attributes applicable for Predictive Stability studies. Experience in using AI/ML and other data science tools to enhance analytical results interpretation and workflow performance. Desirable A good understanding of the overall drug development process from discovery through to launch. Experience of authoring dedicated Predictive Stability elements of drug product regulatory filings. External industry presence in the field of Predictive Stability, including external conferences and working groups. Experience of technical supervision, coaching and mentoring or leading colleagues and scientific projects. Coding experience in Python, R, JMP, MATLAB or similar. Machine learning experience. Skills and capabilities Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of utilising risk-based approaches for successful delivery. Ability to think and operate across boundaries, challenge the status quo and seek opportunities for business improvement. Effective influencing and prioritisation skills to ensure project and strategic delivery. Good communication and partner skills, able to discuss complex ideas in a simple, easy to understand manner. Collaborative work ethic with the ability to work internally and externally across a wide range of partners. Excellent problem-solving skills. Why AstraZeneca? 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 work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world and apply now! We welcome your application no later than April 21st, 2026. Date Posted 07-apr.-2026 Closing Date 18-apr.-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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.