Senior Laboratory Systems Specialist
Core
Subject Matter Expert and project lead for data management and instrument control systems (LIMS, Empower, MODA) supporting biologics pipeline, NPI, and technical transfers in a GMP environment.
Role type
Senior Laboratory Systems Specialist (SME)
Builds
Laboratory instrument control and data management systems for biologics testing and commercialization
Domain
Biopharmaceuticals / Analytical Chemistry / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LIMS configuration, Empower, MODA, analytical method development, data integrity, SDLC, technical transfer, GMP compliance, regulatory knowledge, system harmonization, people leadership
Preferred skills
Bioanalytical method development, HPLC, ELISA, PCR, capillary electrophoresis, bioassays, compendial assays, ERP integration, middleware
Technologies
LIMS, Empower, MODA, SoftMaxPro, LabX, Digital Method solutions, ERP, Middleware
Responsibilities
Lead projects for laboratory instrument control and data management systems; Partner with Lab IT and global System Business Owners; Support business processes and data mapping for ERP/Middleware; Drive system harmonization and standardization; Deliver SME oversight for qualification/validation and technical transfers; Ensure compliance with cGMP, global regulations, and SDLC standards; Provide coaching and mentorship to the Laboratory Systems team
Seniority
Senior, hands-on IC with mentorship responsibilities
