Scientist - MSAT Material Sciences
Core
Lifecycle management of raw materials and product contact materials for commercial manufacturing, ensuring technical, quality, and business requirements are met for robust supply and product performance.
Role type
Senior Scientist (Material Science, Lifecycle Management & Supply Support)
Builds
Compliant supply chains and product quality for commercial biopharmaceutical manufacturing
Domain
Biopharmaceutical manufacturing / Material Science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Material Science, Biotechnology, Chemical/Biochemical Engineering, Lifecycle Management, Change Control, Risk Assessment, GMP, Regulatory Frameworks, Supplier Strategy, Material Selection, Qualification, Issue Resolution, Cross-functional Project Leadership, Stakeholder Alignment, Ambiguity Management
Preferred skills
External Manufacturing Site Experience, CMO Collaboration, CAPA, Lean Supply Chain Management, Validation Testing, Vendor Selection
Technologies
GMP, Regulatory Frameworks
Responsibilities
Drive end-to-end lifecycle management of raw materials across commercial products; Provide technical leadership in supplier strategy, material selection and qualification, issue resolution; Assess impact of supplier and site-driven raw material changes; Provide materials science input into change controls, comparability, and regulatory impact assessments; Support product lifecycle activities including deviations, investigations and continuous improvement initiatives; Serve as Materials Science point of contact for internal/external manufacturing sites and CMOs; Perform and/or review material risk assessments and ensure appropriate control strategies are defined; Support establishing and maintenance of raw material control strategies, including specifications and other documents; Provide inspection-ready documentation and ensure compliance with GMP and regulatory requirements; Lead cross-functional technical projects related to raw material lifecycle management, supplier changes, material investigations, control strategy updates, and external supply support; Translate complex or ambiguous material science challenges into structured problem statements, risk assessments, action plans, timelines, and decision proposals; Drive alignment across MSAT, Quality, Regulatory, Operations, Planning, Procurement, suppliers, and CMOs to ensure timely execution of material-related deliverables; Facilitate technical decision-making in situations with incomplete data by applying risk-based thinking, scientific rationale, and clear escalation pathways
Seniority
Senior, hands-on IC with strategic alignment
