Large Scale mAbs Engineering Project Head
Core
Lead the setup of a new drug substance manufacturing building for large-scale monoclonal antibody (mAbs) production, managing the lifecycle from early enabling works through commissioning and handover.
Role type
Senior IC manufacturing project head (biopharma)
Builds
New drug substance manufacturing facilities and equipment
Domain
Biopharma / Monoclonal Antibodies (mAbs) / Manufacturing Infrastructure
Deliverable
infrastructure
Required skills
Project management, large team leadership, pharmaceutical industry experience, cGMP and regulatory knowledge, CapEx management, COGs optimization, strategic workforce planning, facility integration, process validation oversight
Preferred skills
Multi-site operations experience, global project management, matrix management, process robustness definition
Technologies
None explicitly listed
Responsibilities
Provide overall leadership to the project team ensuring facility and equipment design, installation, qualification, and validation; Ensure Safety & Quality Standards and Regulatory commitments are met; Oversee Engineering, Automation, Maintenance, and C&Q activities; Ensure on-time/on-budget execution; Identify and mitigate project risks; Ensure building compliance with performance targets; Build and execute staffing and training plans; Prepare strategic workforce planning; Integrate new facility within legacy brownfield site; Provide manufacturing schedule for project execution and ramp-up; Manage CapEx and optimize COGs
Seniority
Senior, hands-on IC with strategic oversight
