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 patients’ lives depend on it. People are at the center of everything we do, and when it comes to our employees, we make it personal.

We live by our values:
Audacious—bold;
Dedicated—full commitment;
Candid—honest;
United—collaborate for a common goal.

The Associate Director of CMC Data Science will work with cross‑functional teams while applying the appropriate science‑based techniques to support and create cGMP process monitoring capabilities, design statistically sound lab‑based experiments, solve operations and business problems, support integration of AI into CMC workflows in a compliant manner, and manage the CMC Data Science team. This position is based in our Framingham location and typically requires five days onsite per week.

• 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 as a key contributor to commercial annual product reports.
• Serve as team/project lead with IT for the creation of a data repository for all CMC data (e.g., electronic data warehouse).
• Identify data flow issues, work with end customers to understand needs, and deliver short‑term and long‑term solutions to help scientists/engineers/managers complete deliverables in an agile manner.
• Work with site/group leaders to create tools that better visualize potential risks and issues in critical CMC workflows.
• Embed AI‑enabled CMC business processes into existing workflows to improve efficiency, decision‑making, and innovation.
• Create/advise on DOEs for lab‑based experiments supporting both drug substance and drug product production.
• Drive continuous improvement in cGMP process steps by identifying improvements.
• Contribute to cross‑functional teams to achieve production site and company goals in support of commercial production readiness.
• Manage the data science group to perform similar responsibilities.
• Ensure compliance with the data governance strategy so data consumers can find, access, and use data.

• Practice and promote safe work habits and adhere to safety procedures and guidelines.
• Provide technical representation during internal and external audits.
• Keep up to date with current technologies and trends in biologics manufacturing operations and CMC data trending/warehousing/visualization tools and applications.
• Accept additional duties and responsibilities as required.

• Bachelor’s degree in an applicable field; advanced degree preferred.

• Minimum of 4 years in a data science role, preferably supporting biologics CMC.
• Expertise in statistical analysis, predictive modeling, and data visualization tools.
• Experience with at least one data management system (data lake, data warehouse, or data lake house).
• Experience integrating ML/AI into CMC workflows.
• Demonstrated ability to work in cross‑functional teams.
• Strong organizational skills and attention to detail.
• Experience as a people manager.
• Excellent written and oral communication skills and strong team player.

Base pay range $160k–$207,500. Additional compensation includes an annual performance incentive bonus, new hire equity, and performance‑based equity. Benefits include medical, dental, vision, 401(k) match, flexible time off, and paid holidays.

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to transform cancer treatment by pioneering oncolytic immunotherapies. Our proprietary RPx platform is based on a potent HSV‑1 backbone designed to induce durable systemic anti‑tumor immune responses.

We are an Equal Opportunity Employer.