Principal Engineer CDC

Role Summary

As Principal Engineer Continuous Direct Compression (CDC), you will be responsible for coordinating and leading CDC process and equipment design, development and optimisation on late stage oral solid dose drug product development projects. Building predictive tools and digital twins and CDC process development capability to progress the development of oral small molecules within a dynamic team environment will be your key focus. To deliver these goals, you will work and coordinate collaboratively across boundaries with colleagues with diverse scientific expertise e.g. analysts, formulators, engineers, data scientists, materials scientists and other disciplines e.g clinical supply chain, project leadership, regulatory, outsourcing

Responsibilities

• Lead our engineering capability in CDC, to design and develop robust manufacturing processes for new pharmaceutical formulations, ensuring compliance with industry standards.
• Drive effective technical risk management to ensure that appropriate activities are conducted throughout development to deliver robust commercial manufacture
• Work effectively with colleagues across Global Product Development, Global Operations and at our external manufacturing partners, to define critical process parameters (CPPs) that influence product quality, in consideration of the wider product control strategy
• Expedite adoption and advancement of in silico process modelling and control in CDC, and progress our capabilities in advanced process control
• Lead technology transfer and process validation approaches in CDC
• Liaise effectively across the AstraZeneca technical and supply network to influence network capability requirements for CDC
• Work with equipment manufacturers to evaluate and specify technology improvements, in line with AstraZeneca product and portfolio requirements.
• Provide leadership and coaching to other scientists and engineers within the group, supporting their development to build capability essential to the delivery of the present and future project portfolio.
• Demonstrate creativity and innovation, driving and supporting a culture of scientific excellence in projects.
• Stay updated on industry trends, emerging technologies, and best practices in continuous processing to foster innovation within the organization.

Qualifications

• BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry is essential.
• Minimum 5 years relevant experience
• Industrial experience in pharmaceutical spray drying with a degree in chemical engineering or a closely related scientific discipline.
• Industrial experience in CDC with a degree in chemical engineering or a closely related scientific discipline.
• Experience and thorough understanding of oral solid dose drug product development and commercialisation process
• Proven track record of delivering multiple and/or complex late-stage oral drug product development projects, including technology transfer, scale up and validation of CDC processes
• Experience of using predictive science / digital tools
• Experience in development of drug product control strategies, bringing together different aspects of pharmaceutical sciences.
• Strong collaborative working and communication skills, including ability to work effectively with colleagues from diverse backgrounds and different skill areas.
• Good organisational and planning skills with the ability to deliver to agreed time and quality.
• Excellent stakeholder management skills

Skills

• Experience in development, scale up and technology transfer of a range of other drug product manufacturing processes, eg granulation, tablet compression, coating
• Experience in clinical and commercial regulatory authoring and defence.
• Experience of working with external suppliers (such as CMO/CRO for outsourced development and supply) and managing productive relationships.
• Experience with automation platforms and process modelling