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Overview
Summary of job description:
Replimune is a fast-paced growing innovative company that has brought on-line a brand-new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space. Working in collaboration with cross functional teams, the Data Scientist will apply data science techniques to:
• support GMP process monitoring capabilities
• support designing statistically sound lab-based experiments
• solve operations and business problems
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities
Key responsibilities:
• Provide technical expertise and support to serve as an authority in GMP process monitoring and key contributor to commercial annual product reports.
• PD representative within the CPV program working with other stakeholders (e.g. Validation and QA)
• Support implementation of a data governance strategy for operations to better enable data consumers to find, access, and use data
• 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 IS, serve as a subject matter expert to support creation of data repository for all CMC data.
• 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
• Additional duties and responsibilities as required
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 process development characterization.
Qualifications
Educational requirements:
• Master’s degree in applicable field and 1 to 2 years of related work experience
OR
• Bachelor’s degree in applicable field and 3 to 4 years of related work experience
Experience and skill requirement:
• Minimum of 1 year working in data science role, preferably in a biologics drug substance and/or drug product process development / manufacturing support role.
• Proficient 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)
• Demonstrated ability to work in cross-functional teams across the business.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills and strong team player
Location:
This position is based in our Framingham location and typically has a 5-day on-site expectation.
