Principal Engineer

Summary
:

As Principal Engineer (Spray Drying), you will be responsible for coordinating and leading spray drying process design, development and optimization on late-stage oral solid dose and inhaled drug product development projects. Building manufacturing process robustness, scale up, modelling and simulation capability to progress the development of both small and large 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.

Key Responsibilities
:

• Lead our engineering capability in spray drying, to design and develop robust manufacturing processes for new pharmaceutical formulations, ensuring scalability and compliance with industry standards.
• Evaluate, select, and specify spray drying equipment and technologies that best meet project and production requirements.
• Work effectively with colleagues across Global Product Development, and at our manufacturing partners, to define critical process parameters (CPPs) that influence product quality, in consideration of the wider product control strategy
• Take the lead in defining the regulatory strategy for spray drying in drug products
• Drive effective technical risk management to ensure that appropriate activities are conducted throughout development to deliver robust commercial manufacture
• Expedite adoption and advancement of in silico process modelling and control in spray drying
• Lead technology transfer, scale up and process validation approaches in spray drying
• 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 spray drying to foster innovation within the organization.

Essential Requirements:

• 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.
• Experience and thorough understanding of the overall pharmaceutical drug product development and commercialization process, particularly in oral solid dose
• Proven track record of delivering multiple and/or complex late stage spray drying drug product development projects, including technology transfer, scale up and validation
• 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 organizational and planning skills with the ability to deliver to agreed time and quality.
• Excellent stakeholder management skills

Preferred Skills & Knowledge

• Experience in development, scale up and technology transfer of a range of other drug product manufacturing processes, eg tablet compression, coating
• Experience in clinical and commercial regulatory authoring and defense.
• Experience of working with external suppliers (such as CMO/CRO for outsourced development and supply) and managing productive relationships.
• Experience with inputting user requirements into capital projects.

At Blake Rian Consulting, we are committed to finding the perfect match for every role. Our approach to recruitment goes beyond meeting job requirements; we focus on aligning candidates with company culture and values, fostering lasting, mutually beneficial relationships.