Hobson Prior is seeking a Director of Technical Services for a role involving overseeing and running the validation, technical transfer and introduction of new products, ensuring compliance with GMP and regulatory requirements. The role will support the transition from clinical supply to commercial manufacturing, focusing on Plasmid Manufacturing & gene therapy products. Please note that to be considered for this role you must have the right to work in this location. Responsibilities: Develop and implement validation strategies for manufacturing processes, equipment and systems. Lead site audits and inspections, explaining validation strategies to regulators. Manage the technology transfer of new products and manufacturing processes from development to commercial production. Build and lead the team responsible for the introduction of new products into manufacturing. Lead and mentor a team of validation and technical transfer specialists. Lead risk assessments and develop mitigation strategies for validation and technical transfer projects. Ensure all activities comply with regulatory requirements and support regulatory submissions. Key Skills and Requirements: Bachelor's Degree in Biopharmaceutical Validation, Engineering, or a related Science discipline. Advanced degree is preferred. Previous working history in a biotechnology or pharmaceutical industry. Proven track record in technology transfer and new product introduction. Knowledge of GMP, ICH guidelines, and regulatory requirements in Europe, Japan and USA. Regulatory knowledge and compliance. Leadership and team management skills. Problem-solving and analytical thinking abilities. Technical expertise in validation and technical transfer. Project management and organizational skills. Strong communication and interpersonal skills. Fluent in English, both verbal and written. For more information, please contact Jessica Taylor. Apply now: If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV.
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