Sr. Advanced Specialist Clinical Manufacturing Operations And Sciences, Viral Vector
Legend Biotech
Somerset, NJ, United States
On-site
Viral vector gmp manufacturing
Phase 1 clinical trial material
Technical strategies and execution
Responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and delivering Phase 1 clinical trial material for several viral vector pipeline assets to patients in need
Job Summary
Responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and delivering Phase 1 clinical trial material for several viral vector pipeline assets to patients in need.
Create and author manufacturing procedures necessary to operate a viral vector suite within a GMP manufacturing facility at Phase 1 clinical standards and author facility risk and gap assessments for implementation of GMP viral vector manufacturing.
Represent viral vector manufacturing operations as technical SME in cross-functional meetings and project teams, providing subject matter expertise minimally on manufacturing operations, execution trends, and manufacturing requirements.
Matching Summary
Responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and delivering Phase 1 clinical trial material for several viral vector pipeline assets to patients in need.
Skills & Requirements
Must-have
viral vector GMP manufacturing
Phase 1 clinical trial material
technical strategies and execution
manufacturing procedures and batch records
investigation and deviation management
Nice-to-have
foster a culture of quality and compliance
continuous improvement initiatives
cross-functional team collaboration
Key Requirements
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred
5+ years of experience in viral vector GMP manufacturing
Knowledge and experience with viral vector manufacturing and tech transfer