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For Companies OverviewScientist – 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.
Focus 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
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