This role involves managing and improving quality systems across CSL's European and global affiliates, ensuring compliance with regulatory requirements and CSL standards. Responsibilities include coordinating inspection readiness, maintaining quality KPIs, and supporting global quality initiatives.
The Quality Manager role involves maintaining and improving CSL's quality management systems across Europe and global affiliates. Responsibilities include coordinating inspection readiness, supporting compliance activities, and implementing global quality initiatives. The role requires strong knowledge of pharmaceutical regulations and quality systems, with a focus on collaboration and process improvement.
This role involves leading CMC regulatory strategy for global mRNA product development, preparing and reviewing regulatory submissions, and guiding cross-functional teams on compliance and agency interactions. The position requires deep expertise in biologics CMC regulations, particularly in EU and ROW markets, and plays a key part in shaping regulatory pathways across vaccines, oncology, and rare diseases. Based at the Harwell site, it emphasizes in-office collaboration within a multidisciplinary team.
This role involves leading scientific strategy and execution for immunogenicity and ligand binding assays (LBA) in support of Moderna’s mRNA-LNP therapeutic programs. The Principal Scientist will oversee regulated bioanalytical activities including assay development, validation, and sample analysis, ensuring compliance with GcLP, GLP, and GCP standards. The position plays a key role in clinical development by generating high-quality data to inform regulatory submissions and advance innovative medicines, with opportunities to engage in AI-enabled and digital analytical approaches.
Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development. Interprets safety data, identifies and escalates safety signals, and delivers evidence-based recommendations to inform benefit–risk decisions. Engages with global governance, regulatory authorities, and cross-functional teams to shape the safety profile of innovative oncology medicines.
This role involves providing hands-on engineering and technical leadership to support the introduction, scale-up, and routine manufacturing of new products within a regulated pharmaceutical environment. The Senior Engineering Technician will lead technical activities in Q Block, ensuring equipment readiness, compliance with GMP standards, and successful product launches through close collaboration with cross-functional teams. Key responsibilities include managing change controls, supporting validation, and driving continuous improvement based on technical learnings from new product introductions.
Lead the development and execution of nonclinical safety strategies for small molecule drug candidates in oncology and non-oncology programs, integrating AI-driven predictive models with traditional toxicology. Build and scale the nonclinical safety function within an AI-first drug discovery environment, ensuring high-quality data feedback to refine computational models. Collaborate across preclinical, clinical, and regulatory teams to advance compounds through IND and NDA/MAA-enabling studies.
The Clinical Development Medical Director is responsible for providing medical and scientific oversight for clinical trials, ensuring patient safety, and contributing to the design and execution of clinical studies. They will also participate in safety reviews, interact with healthcare professionals, and support regulatory activities.
The Clinical Development Medical Director is responsible for providing medical and scientific oversight for clinical trials, ensuring patient safety, and contributing to the design and execution of clinical studies. They will also participate in safety reviews, interact with healthcare professionals, and support regulatory activities.
