This role involves managing and maintaining quality systems, ensuring compliance with regulatory requirements, and supporting inspection readiness across CSL's global affiliates. You will collaborate with various functions to implement quality initiatives and improve processes.
Leads global safety strategy for formulation safety across the product lifecycle, focusing on clinical safety evaluation, signal detection, and risk management. Oversees production of key pharmacovigilance documents and ensures compliance with regulatory standards. Acts as safety representative in cross-functional teams and drives safety specifications and risk mitigation plans.
Lead the technical development and implementation of a new labeling and secondary packaging operation at Moderna’s Harwell site, from initial design through commissioning and validation. Establish maintenance strategies, ensure GMP compliance, and drive continuous improvement using engineering excellence principles and digital tools. Build and lead a high-performing engineering team to support long-term operational success in a regulated biotech environment.
This role involves operating and maintaining equipment in a cGMP-regulated mRNA vaccine production environment, ensuring safe and compliant manufacturing processes. The associate will execute production operations, support quality assurance, troubleshoot technical issues, and contribute to continuous improvement initiatives. Work is conducted in a highly automated, digitally enabled facility with a focus on operational excellence and innovation in mRNA technology.
This role involves performing analytical characterisation of biotherapeutics using mass spectrometry and chromatography techniques. You will develop and optimise analytical methods, support early-phase portfolio progression, and collaborate across matrix teams in Discovery and CMC Development.
This role involves leading medical monitoring and safety oversight for gastrointestinal (GI) oncology clinical trials, contributing to study design, data interpretation, and regulatory interactions. The Medical Director integrates physician-level expertise into clinical development, working within cross-functional teams to ensure patient safety and scientific integrity. The position plays a key role in translating clinical data into actionable insights for advancing cancer treatments with high unmet need.
The Clinical Development Medical Director is responsible for providing medical and scientific oversight for clinical trials, ensuring patient safety, and designing clinical studies. They will also participate in committees, review compounds for in-licensing, and support new business development.
Leads global development of a respiratory medicine from clinical proof of concept to approval, serving as the single point of accountability. Builds and leads a cross-functional matrix team to deliver evidence-based strategies, regulatory approvals, and lifecycle planning. Engages with regulators, senior management, and external stakeholders to advance patient-focused drug development.
Leads global development of a respiratory medicine from clinical proof of concept to approval, serving as the single point of accountability. Builds and leads a cross-functional matrix team to deliver strategic development plans, regulatory submissions, lifecycle management, and stakeholder engagement. Works across R&D, manufacturing, commercial, and regulatory functions to drive evidence-based decision-making and optimal patient outcomes.
Leads global development of a respiratory medicine from clinical proof of concept through to approval, serving as the single point of accountability. Builds and manages a cross-functional matrix team to deliver strategic development plans, regulatory submissions, and lifecycle management. Interfaces with senior leadership and external stakeholders to advance patient-focused innovation.
Leads global medicine development from clinical proof of concept through to approval, serving as the single point of accountability for a respiratory asset. Builds and leads a cross-functional matrix team to define strategy, drive evidence generation, and ensure regulatory and commercial success. Interfaces with senior leadership and external stakeholders to shape lifecycle planning and patient-focused development.
