Sr. Scientist, Process Development & Technology
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
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
- vision insurance
- 401k match
- flexible time off
- paid holidays
- year-end shutdown
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What This Job Offers
Job Type
Full-time
Career Level
Senior
