Scientist – Extractables & Leachable Specialist

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