Principal Manufacturing Sciences & Technology Engineer
Core
Lead equipment selection, CMO strategy, and process validation for cGMP drug product manufacturing operations.
Role type
Principal Manufacturing Sciences & Technology Engineer (Process Sciences Drug Product Engineering)
Builds
cGMP drug product manufacturing operations and technology transfer
Domain
Biopharmaceutical manufacturing / cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing operations)
Required skills
Drug product manufacturing, Product development, Process validation, Technology transfer, cGMP compliance, Contract Manufacturing Organization (CMO) management, Equipment qualification, Root cause analysis, CAPA implementation, Process capability trending, Regulatory knowledge (FDA, EMA, MHRA)
Preferred skills
Chemical Engineering, Biomedical Engineering
Technologies
cGMP, Annex I, FDA, EMA, MHRA
Responsibilities
Provide technical lead and subject matter expert support for drug product manufacturing process transfer and new product introduction; Track and report project milestones for raw material procurement, equipment readiness, and analytical transfer; Review and approve cGMP batch documentation including master batch records and validation protocols; Monitor cGMP compliance at contract manufacturers to protect product integrity; Trend process performance to establish and improve process capability; Investigate deviations, determine root cause, and implement CAPA; Lead or assist in equipment selection, qualification, and start-up activities; Partner with Strategic Sourcing to define technical requirements for raw materials and equipment.
Seniority
Principal, hands-on IC with strategic oversight
