Sr. Scientist, Process Development & Technology

Overview

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.

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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Working in collaboration with cross functional teams, the Senior Process Development Scientist – Materials Attributes and Technologies will support the development of control strategies for predominantly single use disposable materials used in the commercial manufacturing of Replimune products. The Senior Process Development Scientist – Materials Attributes and Technologies will serve as a subject matter expert for processing materials, assessing and defining their suitability, compatibility and robustness for use.

In addition, there will be opportunities to lead projects for process characterization and/or support the introduction of new process technologies.

• Serve as a materials subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective, and preventative actions, and supplier change notifications.
• Lead technical material risk assessments to consider impact to supply, processes, products, and customers.
• Help build a material trending program to monitor material performance, potential process performance shifts as a result of change notifications, and consistency of quality attributes.
• Lead process characterization experiments and process validation exercises.
• Provide technical expertise to troubleshoot material issues within drug substance and drug product production. Be an active permanent member of site material review board.
• Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of alternative technologies.
• Collaborate with QC Analytical team to evaluate, test, and assess extractables and leachables from plastic component materials used in the production process.
• Actively contribute to cross functional teams to achieve production site and company goals in support of commercial production readiness.
• Assist with authoring sections of applicable regulatory filings.
• Additional duties and responsibilities as required.

• 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 support.

• Bachelor’s degree in applicable field with advanced degree preferred.

• Minimum of 2 year working in a materials science role, preferably in a biologics drug substance and/or drug product process development / manufacturing support role.
• Experience with single-use manufacturing technology materials (plastics, glass, etc.).
• Experience with ultra-low cold chain insulation materials / development.
• 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.

Replimune is…