Operations Leader (OSD Manufacturing)
Core
Lead production of high-quality pharmaceutical drug products in a regulated environment, ensuring compliance, safety, and operational excellence.
Role type
Senior Operations Leader (Pharmaceutical Manufacturing)
Builds
Pharmaceutical drug products (Oral Solid Dose)
Domain
Biopharmaceuticals / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory standards knowledge (FDA/HPRA), team leadership, resource planning, KPI monitoring, safety culture management, process improvement, shift flexibility
Preferred skills
Oral Solid Dose experience, supervisory experience in highly automated environments, process improvement leadership
Technologies
Manufacturing execution systems, personnel systems
Responsibilities
Oversee drug product manufacturing operations, lead and develop a team of 8-45, plan staffing and material resources, monitor KPIs (yield, production rate, resource usage), manage regulatory inspections/audits, support HR processes, lead OpEx initiatives
Seniority
Senior, hands-on IC with supervisory responsibilities