Manufacturing Manager (Drug Substance)
Core
Oversee drug substance manufacturing operations, including conjugation reactions, purification, and facility management, ensuring strict GMP compliance.
Role type
Manufacturing Manager (Drug Substance)
Builds
Drug substance batches for biopharmaceutical products
Domain
Biopharmaceutical manufacturing (ADC, sterile)
Required skills
GMP compliance, sterile manufacturing, team leadership, shift management, equipment qualification (FAT/SAT/IQ/OQ/PQ), deviation/change control management, SOP development, regulatory knowledge (FDA/HSA/NMPA/EU/ICH), electronic quality systems (TrackWise, MasterControl, GAIA)
Preferred skills
ADC manufacturing, CMO systems, Single-Use Technologies (SUT), downstream processing, bioconjugation
Technologies
TrackWise, MasterControl, GAIA
Responsibilities
Execute manufacturing operations and process documentation; oversee equipment qualification and facility maintenance; lead quality, compliance, and audit activities; manage shift operations and team performance; handle ad-hoc leadership tasks
Seniority
Senior, hands-on IC with leadership duties
