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 Requirements
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 for marketing applications and lifecycle management, including responses to Health Authority questions.
Clear and effective written and verbal communication skills.
Strong project management, organisational and stakeholder-management skills.
Desirable Experience/Knowledge
Master’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Pharmacy or a related field.
Broader experience in biologics manufacturing, CMC, process development, or technical or analytical development.
Experience across multiple modalities, such as monoclonal antibodies and antibody-drug conjugates.
Experience applying AI tools in scientific, technical or regulatory workflows, including drafting, summarisation, data mining and information retrieval.
Ability to critically evaluate AI-generated outputs and identify when scientific correction or subject-matter expert escalation is required.
Understanding of CMC regulations and guidance governing biotechnology products.
Lean capability and experience of risk management.
Are you already imagining yourself in this role? Good, because we can’t wait to hear from you!
Why AstraZeneca
At AstraZeneca, you will be part of a community united by one purpose: delivering medicines to patients quickly, reliably and sustainably. Your scientific perspective and judgement will be valued as you connect people, processes and knowledge across a global network. You will have the opportunity to influence how high-quality CMC content is created, strengthen responsible use of AI in technical authoring and grow alongside skilled colleagues working at the forefront of biopharmaceutical development and manufacturing.
What’s next
If this sounds like an opportunity where you can bring your strengths, deepen your expertise and help shape the future of CMC technical authoring, we would love to hear from you.
We look forward to getting to know you. Please submit your application no later than November 17, 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.
