Associate Director, CMC Data Science & AI Enablement

Replimune; Framingham (MA); On-site; USD 160,000 - 208,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Paid holidays

Job summary

Replimune is seeking an Associate Director of CMC Data Science based in Framingham, MA. You will guide cross-functional teams applying rigorous statistical methods, design experiments, and build data systems to monitor GMP processes. This role drives AI integration into CMC workflows and oversees the data science group.

You’ll lead data governance and analytics for production readiness, manage a team, and shape strategic data initiatives with senior stakeholders.

Qualifications

• Minimum 4 years in a data science role, preferably in biologics CMC.
• Expert in statistical analysis, predictive modelling, and data visualization.
• Experience with at least one data management system (data lake, data warehouse, or data lake house).
• Experience with ML/AI integration into CMC workflows.
• 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 in GMP process monitoring (CPV) and contribute to commercial annual product reports.
• Lead data repository creation for all CMC data (e.g., electronic data warehouse) with IT.
• Identify data flow issues and deliver short/long-term solutions in an agile manner.
• Develop tools to visualize risks and issues in CMC workflows.
• Embed AI-enabled CMC business processes into existing workflows to improve efficiency.
• Create/advise DOEs for lab-based experiments supporting drug substance and product production.
• Drive continuous improvement in cGMP process steps and production readiness.

Skills

Statistical analysis

Predictive modelling

Data visualization

Cross-functional collaboration

People management

Communication

Organizational skills

ML/AI integration

Education

Bachelor’s degree

Tools

Data Lake

Data Warehouse

Data Lakehouse

Job description

Replimune is seeking an Associate Director of CMC Data Science based in Framingham, MA. You will guide cross-functional teams applying rigorous statistical methods, design experiments, and build data systems to monitor GMP processes. This role drives AI integration into CMC workflows and oversees the data science group.

You’ll lead data governance and analytics for production readiness, manage a team, and shape strategic data initiatives with senior stakeholders.