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 RangeReplimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $160k-$207,500 The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
