Manufacturing Scientist II
Core
Develops and validates scientific methodologies for controlling raw materials, production intermediates, and final products in sterile manufacturing, filling, freeze drying, and packaging areas.
Role type
Manufacturing Scientist II (Sterile Products)
Builds
Manufacturing processes and quality control protocols for sterile pharmaceutical products
Domain
Pharmaceutical manufacturing / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Good Manufacturing Practices (GMP), technical writing, process validation, cross-functional team leadership, project management, SOP authoring, CAPA management, critical thinking, Microsoft Office Suite proficiency
Preferred skills
Pharmaceutical industry experience, pre-clinical/clinical/post-marketing drug development knowledge, change control management
Technologies
Electronic Quality Management Systems, Document Management Systems, Microsoft Office Suite
Responsibilities
Author and improve procedures including SOPs, Batch Records, Protocols, and training documents; Lead cross-functional investigation teams for CAPA closure; Manage project timelines and deliverables; Liaise with internal Quality, Operations, Engineering, and Validation teams; Evaluate and contribute to the design of manufacturing processes; Present technical recommendations internally.
Seniority
Mid-level IC (2-4 years experience)
