Scientist I, Analytical Development

Replimune; Montreal (administrative region); On-site; CAD 85,000 - 105,000; Full time

Job summary

Replimune is seeking an experienced Scientist I, Analytical Development to perform routine analytical testing and support AD, PD, and QC projects. This on-site role in Milton Park involves method development, qualification, validation, and data analysis to ensure regulatory compliance and product quality.

The position requires a Bachelor’s in a biological science (MSc/PhD preferred) and 4–5+ years in a cGMP environment, with strong teamwork, communication, and IT skills.

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.
• Ability to work independently and as part of a small team, with effective communication.
• Experience in cell culture, ELISA, PCR, chromatography.
• Strong IT skills in Word, Excel, Outlook and statistical analysis.

Responsibilities

• Perform in-house in-process and stability testing to support Process Development, Analytical Development, Research and Quality Control testing.
• Provide support by performing analytical method development and product characterisation projects.
• Prepare laboratory reagents and controls for routine testing and development projects.
• Support development of robust analytical test methods compliant with regulatory guidelines.
• Execute qualification and validation of analytical methods and technology transfer per ICH guidance.
• Participate in data analysis and routine GMP documentation.
• Maintain calibration of lab equipment and housekeeping tasks.
• Train team members in equipment usage and maintenance.

Skills

Time management

Independent worker

Communication

Team collaboration

Education

Bachelor’s degree in biological sciences

MSc or PhD preferred

Tools

Cell culture

ELISA

PCR

Chromatography

Microsoft Word

Microsoft Excel

Outlook

Statistical analysis

Job description

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.

At Replimune, We Live By Our Values

Audacious: We Are Bold.

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,

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.

At Replimune, We Live By Our Values

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary Of Job Description

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 position is based in our Milton Park location and typically has a 5-day on-site expectation.

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)
• Perform review of assay sheets, lab books and GMP documentation.
• Other duties, as assigned.
• Training team members in equipment usage and maintenance.

Educational Requirements

Education will be appropriate to specific job requirements. The following educational

Requirements Are a Minimum

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

Experience And Skill Requirement

• 4-5+ 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

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.