Staff External Manufacturing Specialist (Clinical Drug Product)
Core
Technical and operational authority for clinical contract drug product (DP) filling operations at CMO sites, owning end-to-end tech transfer and active batch management.
Role type
Staff External Manufacturing Specialist (Clinical Drug Product)
Builds
Clinical drug products via sterile filling, lyophilization, and related unit operations at contract manufacturing organizations.
Domain
Biopharmaceutical manufacturing, sterile processing, GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
aseptic filling operations, sterile filtration, lyophilization cycle development, environmental monitoring data interpretation, cleanroom design assessment, extractables and leachables risk assessment, technical transfer leadership, deviation investigation, CAPA development, GMP decision-making, cross-functional collaboration
Preferred skills
CMO oversight, process validation, continuous improvement initiatives, regulatory submission support (CMC sections)
Technologies
isolator/RABS, vial/syringe filling systems, lyophilizers, depyrogenation tunnels, washers, autoclaves, time-pressure fillers, peristaltic fillers, rotary piston fillers
Responsibilities
Lead end-to-end tech transfer to CMO filling sites including gap assessments and validation; manage active clinical batches tracking status and lot disposition; serve as primary technical resource for mid-level specialists on aseptic operations; lead deviation investigations and drive CAPA closure; ensure cGMP compliance at external manufacturing partners; review CMO change controls for regulatory impact.
Seniority
Staff, hands-on IC with mentorship and strategy
