Manufacturing Production Specialist (Drug-Linker)
Core
Hands-on manufacturing specialist supporting the startup and routine GMP production of high-potency drug-linker intermediates and small molecule APIs in a high-containment biologics facility.
Role type
Manufacturing Production Specialist (Drug-Linker)
Builds
High-potency drug-linker intermediates, small molecule APIs, and supports the startup of a new ADC manufacturing campus.
Domain
Biopharmaceuticals / Antibody-Drug Conjugates (ADC) / High-Potency Compounds
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Small molecule GMP operations, high-containment technologies (isolators, RTPs), equipment qualification (FAT/SAT/IQ/OQ/PQ), GMP documentation, deviation management, change control, CAPA, process safety, root cause analysis
Preferred skills
ADC linker or payload synthesis, cleaning validation, equipment performance verification, Lean Six Sigma, structured problem solving
Technologies
Reactors, filter dryers, isolators, chromatography systems, HPLC, solvent recovery equipment
Responsibilities
Support FAT/SAT, commissioning, and IQ/OQ/PQ for key production and containment systems; Contribute to SOPs, batch record design, and operator training; Drive line readiness, setup, changeovers, and troubleshoot deviations; Coordinate with EHS for cGMP, process safety, and risk assessments; Prepare, review, and implement qualification protocols and test records
Seniority
Mid-Senior, hands-on IC
