Sr. Scientist, Process Development & Technology

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.

Responsibilities

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 and 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

Requirements

Bachelor’s degree in applicable field; 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

Nice to have

Advanced degree preferred; Experience in a biologics drug substance and/or drug product process development / manufacturing support role preferred

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown