Associate Director, CMC Data Science

Replimune•Framingham, MA

2d•$160,000 - $207,500•Onsite

About The Position

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. 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, and manage the CMC Data Science team. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

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

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
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