Biologics Manufacturing Technical Expert III
Core
Design, startup, and operation of a new Single-Use Biologics Drug Substance (DS) manufacturing facility in Foster City, CA.
Role type
Senior IC Biologics Manufacturing Technical Expert
Builds
A new state-of-the-art Single Use DS Biologics Manufacturing facility
Domain
Biologics manufacturing, Single-Use technologies, cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics DS operations, Single-use technologies, cGMP compliance, Process validation, Equipment design input, GMP documentation, CAPA management, Quality Risk Management, AI tool application, Cross-functional collaboration
Preferred skills
Digital manufacturing solutions, Automation integration, Process improvement, Regulatory submission support
Technologies
Single-use systems, AI tools, Digital manufacturing platforms, Automation systems
Responsibilities
Execute first-time readiness for unit operations and workflows; Act as technical first responder during campaigns; Directly execute and document key operations on the plant floor; Execute full-scale process and equipment validation studies; Provide manufacturing end-user input to facility and equipment design decisions; Author and review GMP documentation (SOPs, work instructions, batch records, validation protocols/reports); Initiate, investigate, and support CAPAs for GMP deviations; Participate in Quality Risk Management (QRM) activities; Support health authority interactions during site inspections and regulatory submissions.
Seniority
Senior, hands-on IC