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