CMC Technical Authoring Manager – Global Technical Operations

Do you want to turn complex science into clear, submission-ready CMC content that helps medicines reach patients? Join us as CMC Technical Authoring Manager in Global Technical Operations and bring together scientific insight, regulatory understanding and smart use of AI-enabled tools. In Operations at AstraZeneca, we have a bold ambition: to deliver more medicines to patients, faster and more affordably. Global Biologic Operations is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations and biopharmaceutical manufacturing.  Global Technical Operations (GTO) plays a critical role in making that ambition real by connecting technical expertise, manufacturing knowledge and regulatory delivery across our biologics portfolio. Your opportunity to make a difference This is an opportunity to join GTO/CMC Technical Authoring and take ownership of high-quality Chemistry, Manufacturing and Controls (CMC) contributions for designated biologic products. Based in Södertälje, you will work in a global, cross-functional environment and report to Senior Director within CMC Technical Authoring. You will combine scientific and technical knowledge with project leadership to support marketing applications and post-approval submissions. You will also help shape how we use AI-enabled authoring responsibly, applying expert judgement to ensure every output is accurate, compliant and fit for purpose. What you will do You will project manage and deliver CMC content across the product lifecycle, using both established authoring approaches and AI-enabled tools. Working closely with regulatory, technical, manufacturing, analytical and quality partners, you will translate complex information into clear contributions for internal and external regulatory stakeholders. You will be able to connect knowledge across products, adapt to evolving submission requirements and regulatory expectations, and confidently decide when AI-assisted content needs correction or further subject-matter expert input . Key Responsibilities You will: • Author and deliver approved, submission-ready CMC contributions for marketing applications and post-approval submissions. • Generate and coordinate responses to Health Authority questions, including evaluating and refining AI-assisted drafts where appropriate. • Ensure human-authored and AI-generated content is technically accurate, regulatory-compliant, delivered to agreed timelines and fit for its intended purpose. • Apply strong project management to changing submission requirements, evolving AI capabilities and the wider regulatory landscape. • Maintain and apply knowledge of biologics development, manufacturing processes, control strategies, analytical methods and relevant regulatory guidance. • Connect learning across biologic products to support consistent strategies, content reuse and effective prompt design. • Collaborate across GTO, CMC Regulatory Affairs, iCMC, BioOps sites, Quality, BPD and External Sourcing, as well as with alliance partners and CMOs. • Contribute to process optimisation, digital and AI-driven improvements, capability building, training and risk-based decision-making. • Support effective resource planning and coordinate or contribute to ISPR development using AI tools where applicable. Essential Requirement s • Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Pharmacy or a related field. • At least two years of experience in biologics manufacturing, CMC, process development, technical or analytical development. • Strong understanding of biologics manufacturing principles, analytical methods and control strategies. • Experience authoring CMC documentation fo