Senior Specialist, Drug Product Operations
Core
Lead drug product manufacturing operations for Antibody Drug Conjugate (ADC) facilities, ensuring GMP compliance and successful product launches.
Role type
Senior Specialist, Drug Product Operations (Manufacturing)
Builds
High-potency ADC drug products for oncology patients
Domain
Biopharmaceuticals / Oncology / ADC Manufacturing
Required skills
Aseptic Manufacturing, Batch Production, Equipment Qualification, GMP Documentation, Pharmaceutical Formulations, Plant Startup, Root Cause Analysis (RCA), Sterile Filling, Sterile Manufacturing, Visual Inspections
Technologies
AVI/MVI, FMEA, Six Sigma
Responsibilities
Execute automation sprints, support equipment qualification (CQV, IQ/OQ), create/revise technical documents (SOPs, batch records), perform FAT/SAT, execute engineering and commercial batches, provide technical expertise in sterile supply/formulation/filling/lyophilization, conduct risk assessments (FMEA), support RFT implementation.
Seniority
Senior, hands-on IC