Jobs at LOTTE BIOLOGICS

Supports automation systems in a biopharmaceutical manufacturing facility, including process and building controls, S88 batch systems, hardware, device integration, networking, configuration, testing, troubleshooting, and 24/7 operational support. Collaborates with manufacturing, engineering, quality, validation, facilities, and IT teams while ensuring cGMP, EHS, documentation, and regulatory compliance. The role also contributes to automation projects, root-cause investigations, system implementations, and continuous improvement initiatives.

Serves as the technical SME for ADC manufacturing across clinical and commercial programs, leading conjugation, purification, formulation, scale-up, technology transfer, process validation, and continuous improvement. Supports floor operations, deviation investigations, root cause analysis, CAPA, audits, regulatory responses, documentation, risk assessments, and cGMP compliance. Collaborates cross-functionally with manufacturing, quality, automation, HSE, facilities, supply chain, and process development teams while mentoring junior engineers. The role requires work in cleanrooms and around hazardous, highly potent compounds.

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.

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.