Technical Shift Lead
Core
Lead technical operations and manufacturing activities in a biologics fill-finish facility, ensuring product quality, regulatory compliance, and cost-effective delivery.
Role type
Senior manufacturing shift lead (biologics fill-finish)
Builds
Commercial and NPI clinical manufacturing products
Domain
Pharmaceutical/Biologics manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch processing, automation, commissioning, validation, cGMP compliance, aseptic processing, contamination control, regulatory interaction (FDA/HPRA), OEE optimization
Preferred skills
Direct supervisory experience, advanced degree in chemistry/pharmacy/engineering
Technologies
Fill-finish equipment, lyophilization systems, buffer preparation systems
Responsibilities
Lead team to deliver compounding, filling, lyophilization, and processing activities; Coach and mentor manufacturing team; Promote contamination control culture; Collaborate with supply chain, quality, and engineering for planning and execution; Resolve operations issues; Interface with QA and health authorities.
Seniority
Senior, hands-on IC with supervisory responsibilities