Scientist, Materials Science

Role: Scientist, Materials Science, providing scientific leadership for the selection, qualification, and lifecycle management of raw materials and product-contact materials used in biologics development and manufacturing. Responsibilities: lead phase-appropriate risk assessments; support extractables/leachables, chemical compatibility, supplier changes, investigations, technology transfer, and regulatory submissions; collaborate across cross-functional teams including Technical Development, Manufacturing, Quality, Regulatory, and Supply Chain; develop standards and communicate findings to stakeholders. Requirements: PhD in materials science, chemistry, chemical engineering, or related, with 2+ years of relevant experience; or MS with 6+ years; or BS with 8+ years in biologics or biopharma manufacturing support. Core expertise in biologic drug development, process chemicals, excipients, resins, filters, or single-use systems; knowledge of GMP, regulatory requirements, and material characterization. Preferred: advanced knowledge in single-use tech, extractables/leachables, or regulatory CMC documentation; strong experimental and technical writing skills; ability to collaborate across disciplines. High-Value: biologics manufacturing, quality systems, regulatory submissions, lifecycle management of materials, support for process performance and product safety. WorkSetup: not specified; likely office-based with laboratory or supplier testing support.