Sr. Director, Operational Excellence - Replimune, Inc.

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.

 At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal.  With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Job Summary:

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.

About Replimune 
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.