Analytical Development Scientist I — GMP Lab Innovator

Replimune; United Kingdom; Remote; GBP 45,000 - 65,000; Full time

Job summary

Replimune is seeking a Scientist I, Analytical Development to perform routine analytical testing supporting Process Development, Analytical Development, Research and Quality Control. The role is based on-site at Milton Park, with a typical 5-day on-site expectation.

You will develop and validate analytical methods, manage reagents and data, and work within a small team to ensure compliant testing and robust characterisation of products for cGMP environments.

Qualifications

• Bachelor’s degree in a relevant biological science is required; MSc or PhD preferred.
• 4-5+ years industry experience in a cGMP Quality environment or similar setting.
• Ability to work independently and in a small team with good communication.

Responsibilities

• Perform in-house in-process and stability testing (PCR, ELISA, chromatography and cell-based tests) to support PD, AD, R&D and QC.
• Support analytical method development and product characterization projects.
• Prepare reagents and standards for routine testing and development projects.
• Develop robust analytical methods compliant with regulatory guidelines and transfer methods as needed.
• Execute qualification/validation of methods and technology transfer per ICH/regulatory guidance.
• Maintain GMP-compliant documentation and perform routine equipment calibration and housekeeping.

Skills

Cell culture

ELISA

PCR

Chromatography

Statistical analysis

Time management

Independent work

Education

Bachelor’s degree in a biological science

MSc or PhD preferred

Tools

Microsoft Word

Excel

Outlook

Job description

Replimune is seeking a Scientist I, Analytical Development to perform routine analytical testing supporting Process Development, Analytical Development, Research and Quality Control. The role is based on-site at Milton Park, with a typical 5-day on-site expectation.

You will develop and validate analytical methods, manage reagents and data, and work within a small team to ensure compliant testing and robust characterisation of products for cGMP environments.