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.

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Scientist I, Analytical Development