Senior MSAT Specialist, Materials
Core
Define standards for manufacturing materials and single-use systems to safeguard patient safety and product quality across biologics, API, and fill-finish operations.
Role type
Senior MSAT Specialist (Materials)
Builds
Reliable, scalable manufacturing solutions for Antibody-Drug Conjugates (ADCs) and biologics
Domain
Biopharmaceutical manufacturing / Materials Science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Material qualification strategy, risk-based assessment, extractables and leachables (E&L) analysis, supplier assessment, GMP compliance, technical problem solving, project management, cross-functional collaboration
Preferred skills
Professional certification, supply chain interdependence knowledge, machinery-equipment-material integration
Technologies
Single-use systems, digital manufacturing tools, automation infrastructure
Responsibilities
Lead risk-based qualification and lifecycle strategies for manufacturing materials; Drive E&L strategies and material compatibility assessments; Evaluate and implement new materials and supplier solutions; Serve as primary point of technical escalation for complex challenges; Mentor specialists and establish technical standards; Collaborate with regulatory, Quality, and Operations teams
Seniority
Senior, hands-on IC with mentorship responsibilities