Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We are looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences. What we doWe are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. Why we love it.The future is bright at AstraZeneca as we bring ground-breaking therapies to complex disease to patients with critical needs. Scientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied work. We are on an exciting journey to pioneer the future of healthcare! The roleAs part of the Integrated Bioanalysis (IBA) Global Team, you will be responsible for leading the design and implementation of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline. You will be intimately involved in ensuring lab-based activities are aligned with context of use. You will work in a matrix manger with to manage aspects such as experimental design and tech transfer and will need to foster s close interaction with other scientific and technical staff in the lab. The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities across Oncology. Working with a dynamic team in a matrixed environment you will need to manage stakeholder expectations, input to project strategy and delivery while being the main interface with experienced and highly skilled bioanalytical scientist colleagues or our partnered labs. You will have the opportunity to have an immediate and lasting impact to our diverse pipeline. 

Overseen assay transfer, scientific quality and study conduct at CRO partners.Deep understanding of global regulatory expectations and guidanceContributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.

Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (humoral and cellular)Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.