Replimune is a fast-paced growing innovative company that is in the process of bringing Oncolytic Immunotherapies to the market to meet unmet medical needs. The Senior Director – Operational Excellence is responsible for multi-site operational performance metrics, ensuring excellence in investigations and change executions, leading global site leadership teams and initiatives, ensuring projects are planned and completed on time including identifying support to meet growing commercial demands. Reporting to the VP, CMC, in Framingham, MA, the incumbent will work closely with internal stakeholders (Process Development, Operations, Engineering, Validation, Facilities, Quality Control and Quality Assurance) to ensure the sites are executing improvements to ensure state of the art production facilities, cost-efficient and compliant to international cGMP requirements.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Primary responsibilities include:

• Establish clear best practices to ensure operations are run efficiently at Framingham and Milton Park sites including harmonizing business processes for daily operational meetings, escalations to Sr Leadership, ensuring everyone is informed, issue resolution, and resource modeling / allocation for major projects
• Manage and update manufacturing site metrics including Key Performance Indicators (KPIs), site leadership meetings and dashboard for ongoing site improvement projects
• Establish Operations toolkit and support of root cause analysis, process mapping, problem solving techniques, new technology deployment, statistical data analysis, reducing waste and optimizing flow of people and materials, etc.
• Identify opportunities for improvement and drive major change management initiatives and priorities for the site including training programs
• Lead operational excellence initiatives or projects towards improving KPIs, and capacity to ensure sites are meeting production goals / demands from commercial forecasts and organizations
• Facilitate Operational Leadership Team to ensure high performance
• Align CMC objectives with teams and senior management to ensure business targets for process and product development and commercial production can be achieved
• Partners with Facilities, Engineering and Validation, Quality and Data Science to ensure effective cross functional alignment on key site initiatives and electronic systems and other duties as assigned

Educational and experience requirements:

• Bachelors degree required with minimum of 12 years work experience in Operations, Manufacturing and / or Process Engineering / Product Development, advanced degree preferred.
• Experience leading and managing site initiatives and projects and strict adherence to timelines with strong track record of improving and streamlining operations in regulated environment
• Technical experience in data and statistical analysis, biologics drug substance, drug product / sterile product development, and/or analytical methods is required
• Certification in Lean Sigma (Green / Black belt) and / or project leadership is preferred
• Strong problem-solving skills; attention to detail and track record of excellent decision making and issue resolution
• Demonstrated ability to work in cross-functional teams and across the business, persuasive and effective negotiation
• Experience in written and oral communication with health authorities (e.g. FDA, EMA)

Location: 

This position is based in our Framingham location and typically has a 5-day on-site expectation.