Associate Director, CMC Data Science

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:

The Associate Director of CMC Data Science will work with cross-functional teams while applying the appropriate science-based techniques to:

• support / creation of cGMP process monitoring capabilities

• design statistically sound lab-based experiments

• solve operations and business problems

• support integration AI into CMC workflows in a compliant manner

• manage the CMC Data Science team

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

Key Responsibilities:

• CMC Statistical Lead and point of contact for statistical analysis requests across the CMC organizations

• Provide technical expertise and support to serve as an authority in GMP process monitoring (CPV) and key contributor to commercial annual product reports.

• Working with IT, serve as a team leader / project lead for the creation of data repository for all CMC data (e.g. electronic data warehouse)

• Identify data flow issues working with end customers to understand needs and deliver short term and long-term solutions to help scientist/engineers/managers complete their deliverables in an agile manner

• Working with site / group leaders create tools to better visualize potential risks and issues to critical CMC workflows

• Work with cross functional customers to embed AI-enabled CMC business processes into existing workflows to improve efficiency, decision-making, and innovation

• Create / advise on DOEs to be used within lab-based experiments supporting both drug substance and drug product production.

• Drive continuous improvement in our cGMP process steps by identifying process improvements

• Actively contribute to cross functional teams to achieve production site and company goals in support of commercial production readiness

• Manage the members of the data science group to perform similar key responsibilities

• Ensure that all data science team members comply with the data governance strategy for operations to better enable data consumers to find, access, and use data

Other Responsibilities:

• Practices and promotes safe work habits and adheres to safety procedures and guidelines.

• Provide technical representation during internal and external audits.

• Keeps up to date with current technologies and trends in biologics manufacturing operations and CMC data trending / warehousing / visualization tools and applications.

• Additional duties and responsibilities as required

Educational Requirements:

• Bachelor’s degree in applicable field with advanced degree preferred

Experience and Skill Requirement:

• Minimum of 4 year working in data science role, preferably in support of biologics CMC.

• Expert in statistical analysis, predictive modelling, and data visualization tools

• Experience with at least one data management system (data lake, data warehouse, or data lake house)

• Experience with ML/AI integration into CMC workflow(s)

• Demonstrated ability to work in cross-functional teams across the business.

• Strong organizational skills and attention to detail.

• Experience as a people manager

• Excellent written and oral communication skills and strong team player

Salary Range

Replimu