Overview
Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values:
United: We Collaborate for a Common Goal.
Audacious: We Are Bold and Innovative.
Dedicated: We Give Our Full Commitment.
Candid: We Are Honest With Each Other.
People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.
Join us, as we reshape the future.
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 for 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.
- Involved in the daily operations of the Analytical Development group and actively participate 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:
- Draft and review analytical reports and standard operating procedures (SOPs).
- Other duties, as assigned.
- Perform review of assay sheets, lab books and GMP documentation.
- Train 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.
