Jobs at LOTTE BIOLOGICS

Leads process engineering ownership for mAb and ADC programs across facility fit, technology transfer, scale-up, PPQ, commercial manufacturing, and lifecycle improvement. Evaluates equipment, utilities, containment, automation, capacity, and GMP requirements; directs risk assessments, investigations, CAPAs, validation, and capital project support. Partners with cross-functional and client teams, authors technical documentation, provides on-floor leadership, and mentors engineers.

Leads site Process Safety Management, electrical safety, energy control, and HSE programs within a regulated biologics manufacturing environment. Responsibilities include PHAs, HAZOPs, risk assessments, MOC reviews, Arc Flash and LOTO compliance, ISO 45001 audits, incident investigations, industrial hygiene monitoring, regulatory compliance, contractor safety, training, metrics, emergency response, and support for manufacturing projects and operational improvements.

Provide QA program management and client-quality oversight in a CDMO environment: execute QA deliverables, review documentation, manage deviations/CAPAs/change control, support NPI and technical transfers, participate in audits, and ensure compliance with cGMP, site procedures, and Quality Agreements.

Provide QC technical support for clients including method transfer, sample testing, data review, and authoring technical documents. Apply microbiological and analytical expertise to troubleshoot instruments/methods, perform data integrity assessments and instrument qualifications, support investigations and corrective actions, and ensure cGMP-compliant documentation and client communication.

Lead site PMO for client-facing and internal biopharma projects, ensuring on-time, on-budget delivery. Establish PMO governance, dashboards, and KPIs; manage cross-functional alignment across Manufacturing, Development, Quality, Supply Chain, and Business Development. Oversee project planning, resource allocation, risk management, change orders, client communications, financial tracking, and technical transfers while supporting audits, site visits, and continuous improvement.

Lead the Syracuse site PMO to establish governance, portfolio management, and delivery disciplines for complex biologics CDMO programs. Oversee project execution, financial oversight, client relationships, risk management, resource planning, and PMO capability building while partnering with global PMO and site leadership to drive predictable, high-quality program delivery.