LOTTE BIOLOGICS Benefits Overview

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.