Sr. Scientist, Process Development & Technology

Replimune • Framingham, MA

3d

About The Position

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.

Requirements

• 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 Haves

• advanced degree preferred

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.
• 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
• 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

Benefits

• medical, dental, and vision insurance
• 401k match
• flexible time off
• a number of paid holidays including year-end shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Senior