Scientist I, Analytical Development

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Job Summary:

Scientist I, Analytical Development is responsible for performing routine analytical testing to support AD, Process Development (PD), Research and Quality Control (QC) projects. Scientist I also provides support to development, optimization, qualification, and validation of analytical methods and AD characterization projects.

This is a fixed-term position for a period of up to one year. Fixed-term employees are eligible Replimune benefits. Position is based in our Milton Park location and typically has a 5-day on-site expectation.

Responsibilities

Key responsibilities:

• Perform in-house in-process and stability testing (PCR, ELISA, chromatography and cell-based analytical tests) to support Process Development, Analytical Development, Research and Quality Control testing.
• Provide support by performing analytical method development and product characterisation projects.
• Prepare laboratory chemical reagents and biological assay standards and controls for use in routine testing and development projects.
• Support the development of robust analytical test methods that are in compliance with regulatory guidelines.
• Execute the qualification and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidance’s.
• Involved in the daily operations of the Analytical Development group and actively participates in method troubleshooting and data analysis.
• Oversee and perform internal periodic maintenance, calibration and verification of laboratory equipment.
• Perform general laboratory housekeeping tasks, including maintaining stock levels of laboratory consumables.
• Operate in accordance with Good Manufacturing Practice (GMP), company procedures and health and safety practices.
  
  

Other Responsibilities

• Drafts and reviews analytical reports and standard operating procedures (SOPs)
• Other duties, as assigned.
• Perform review of assay sheets, lab books and GMP documentation.
• Training team members in equipment usage and maintenance.
  
  

Qualifications

Educational requirements:

• Bachelor’s degree in a relevant biological science is required; MSc or PhD preferred.
  
  

Experience and skill requirement:

• Minimum 4 years' industry experience, preferably in a cGMP Quality environment
• A self-motivated individual, with good time management and able to work in an organised manner.
• An ability to work independently and as part of a small team, with effective communication and an ability to work flexibly to meet varying workloads.
• Ability to interface effectively with management and other groups or project teams.
• Experience in any of cell culture, ELISA, PCR, chromatography.
• Good IT skills in core applications e.g. Microsoft Word, Excel, Outlook and experience in statistical analysis