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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
- Experience in any of cell culture, ELISA, PCR, chromatography.
- 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.
- Good IT skills in core applications e.g. Microsoft Word, Excel, Outlook and experience in statistical analysis
