Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)
Core
Strategic technology partner aligning IT direction with business goals for Biologics Clinical Manufacturing, driving system maturation and value realization.
Role type
Senior IT Business Analysis Specialist
Builds
Web-based solutions (SaaS), specialized Tech Dev Biologics Clinical Manufacturing applications, enterprise technology extensions
Domain
Life Sciences / Biopharmaceuticals / Clinical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Strategic planning, business case development, stakeholder management, process improvement, ROI modeling, roadmap alignment, change management, Agile methodologies, domain architecture alignment, KPI tracking
Preferred skills
GxP compliance knowledge, 21 CFR Part 11 requirements, biopharmaceutical industry experience, IT implementation/integration expertise, cloud transformation experience, data security/compliance understanding, Biologics Clinical Manufacturing process knowledge, Python/R programming, AWS cloud platforms, emerging tech awareness (GenAI, Digital Twin, PAT, AI/ML)
Technologies
Jira, Asana, MES, Electronic Batch Records, ERP Mfg, CMMS, Digital Process Automation, Historian, IOT, AWS
Responsibilities
Participate in strategic planning sessions to identify capability enablement opportunities; develop business use cases, cost structures, and ROI models; align business digital vision with IT initiatives; manage application portfolio and prioritize initiatives; validate business requirements to reduce rework; track post-implementation KPIs; foster team environment and share information with IT members
Seniority
Senior, hands-on IC with strategic planning and team coordination
