Scientist – Extractables & Leachable Speci...

Scientist – Extractables & Leachable Specialist Pharmaceuticals / life sciences / E&L Salary: £55,000k - £80,000k package, relocation available with this role Full time permanent Sector: - Sterile manufacturing - biotechnology, pharmaceuticals, life sciences Market leading Global Organisation Location: Darlington / Tees Vally region / Teesside This is an excellent opportunity to join a global and market leading organisation in a new Scientist Extractables & Leachable Specialist appointment. As the E&L Specialist lead you will be the main technical expert for E&L, responsible for material selection, system design, and sterility assurance. Conduct risk assessments to address E&L hazards across processes and materials, while evaluating new technologies to enhance manufacturing safety and efficiency. Key Areas * Chemistry/ Biology/ Biotech/ Biochem/ Chemical Engineering / Process Engineering / Science based manufacturing * GMP (Good Manufacturing Practice) clinical trial, commercial manufacturing and packaging services * Knowledge of Product Lifecycle Management business processes * Sterile Technical (E&L) environment experience * Knowledge of Product Lifecycle Management business processes Role Responsibilities * Serve as the expert on E&L and leak detection issues, offering specialised knowledge in this field. * Conduct risk assessments to address E&L hazards across processes and materials, while evaluating new technologies to enhance manufacturing safety and efficiency. * Focused on ensuring best practices and compliance with global technical standards * Maintain knowledge of innovative technology and best practices for E&L detection. * Coach and mentor Technologists and others working in wider technical teams, engineering teams, and quality functions. * Continually monitor and assess process capabilities using data to enhance inspection technical process capability. * Establish and implement standards and procedures to ensure compliance with Quality and EHS regulatory standards. * Lead comprehensive risk assessments to evaluate E&L hazards, including extractables testing and leachables profiling for product contact material and equipment. * Oversee contamination control strategies and verify the operational integrity of components. * Ensure day-to-day technical issues are resolved urgently to minimise impact on project(s)/product performance or reject/waste levels Experience/Qualifications * Degree:- Chemistry/ Biology/ Biotech/ Biochem/ Chemical Engineering / Process Engineering / Science based manufacturing * Strong communication skills * High standard of analytical and technical problem-solving skills