Associate Director/Director, CMC Digital Business Partner
Core
Define, deliver, and maintain digital systems to support GMP operations, cell orchestration, and data architecture for a cell and gene therapy company.
Role type
Senior IC digital business partner (CMC/Manufacturing Systems)
Builds
GxP-compliant digital platforms for manufacturing execution, cell orchestration, lab informatics, and ERP integration
Domain
Biotechnology / Cell and Gene Therapy / GxP Compliance
Required skills
GxP compliance (21 CFR Part 11, GAMP 5, CSV/CSA), systems integration (APIs, ISA-95), data architecture, vendor management, lifecycle validation, cold chain logistics, stakeholder influence
Preferred skills
Experience with MES/eBR, LIMS/ELN, cell orchestration (COI/COC), process data historians
Technologies
MES, eBR, LIMS, ELN, ERP, eQMS, APIs, Middleware
Responsibilities
Develop CMC digital strategy and roadmap; translate business needs into digital capabilities; lead technical delivery of GxP systems; define CMC data architecture; establish system governance framework; align QMS processes with industry best practices; oversee digital portfolio and vendor relationships
Seniority
Director level, hands-on IC
