Manufacturing Process Specialist
Core
Provide technical leadership and support for manufacturing operations, specifically in Antibody Drug Conjugation (ADC) and aseptic filling processes.
Role type
Manufacturing Process Specialist (Pharmaceutical/Biologics)
Builds
ADC manufacturing capabilities and drug products
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process validation, batch processing, technical transfers, scale-up, commissioning, cGMP compliance, root cause analysis, statistical process control, project management, technical writing, equipment qualification, regulatory audit support
Preferred skills
lyophilization, sterilization operations, lean methodologies, new product introductions
Technologies
isolator technology, aseptic filling systems, process control systems
Responsibilities
Serve as SME in formulation and aseptic filling; oversee planning and execution of technology transfer projects; lead root cause analysis for process deviations; establish specifications for process parameters and controls; monitor and analyze process data; collaborate with vendors for equipment procurement; represent the team at regulatory audits; implement statistical process control systems.
Seniority
Mid-level, hands-on IC
