Senior GMP Manufacturing & AI Advisor
Core
Senior advisor evaluating manufacturing operations and guiding AI adoption within GMP-regulated pharmaceutical environments.
Role type
Senior IC manufacturing & AI strategy advisor
Builds
AI-driven solutions for vaccine development and manufacturing processes
Domain
Pharmaceutical manufacturing / AI / GxP compliance
Deliverable
production ML models
Required skills
GMP manufacturing expertise, AI implementation in GxP, regulatory compliance (21 CFR Part 11, EU Annex 11), site assessment, stakeholder advisory, batch execution, deviation management, validation frameworks
Preferred skills
Generative AI, AI agents, advanced analytics, digital transformation strategy
Technologies
Generative AI, AI agents, predictive analytics, document automation
Responsibilities
Analyze end-to-end autogenous vaccine development and manufacturing processes; Assess opportunities to introduce AI-driven solutions; Develop and prioritize AI initiatives; Support development of regulatory-compliant organizational frameworks; Assess manufacturing sites for technological maturity; Recommend pilot locations; Conduct stakeholder interviews; Present strategic recommendations; Contribute to design of pilot programs; Define scalable AI deployment strategies
Seniority
Senior, hands-on IC
