Manufacturing Lead
Core
Lead and support manufacturing team to deliver biologics fill-finish activities (compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation, processing) in a regulated facility.
Role type
Senior Manufacturing Lead (Biologics Fill-Finish)
Builds
Commercial and NPI clinical manufacturing products for biologics
Domain
Pharmaceutical / Biologics / Fill-Finish
Required skills
Batch processing, automation, commissioning, validation, cGMP compliance, aseptic processing, contamination control, regulatory affairs (FDA/HPRA), cost reduction, OEE optimization
Preferred skills
Direct supervisory experience, advanced degree in chemistry/pharmacy/engineering
Technologies
Biologics fill-finish equipment, aseptic processing systems
Responsibilities
Act as technical expert and key point of contact for the team; Coach and mentor manufacturing team; Promote contamination control and aseptic best practices; Collaborate with program management, supply chain, quality, and engineering for planning and execution; Resolve operations and project issues; Drive operations excellence and targets including OEE; Interface with QA and health authorities (HPRA, FDA) for audits and compliance.