Associate Director, CMC Data Science

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.

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

Requirements

Bachelor’s degree in applicable field; Minimum of 4 year working in data science role; 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

Nice to have

Advanced degree; Experience in support of biologics CMC

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown