Manufacturing Investigation, Principal Analyst

Role: Manufacturing Investigation Principal Analyst responsible for leading investigations into manufacturing and product deviations to ensure quality, compliance, and operational reliability within Takeda's GMP-regulated biotech manufacturing environment. Responsibilities: coordinate deviation investigations, perform trend analysis, drive root cause analyses, implement CAPAs, maintain investigation procedures, and support inspection readiness and regulatory responses. Engage cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain teams to improve processes and ensure compliance. Requirements: Bachelor's in Life Sciences, Biotechnology, Pharmacy, or Engineering; extensive experience in pharmaceutical/biotech GMP manufacturing; proven expertise in deviation investigations, root cause analysis, CAPA management, and GMP quality systems; strong communication and stakeholder management skills. High-Value: biologics manufacturing, GMP compliance, deviation investigation, quality management, regulatory inspection support, possible involvement in continuous improvement projects. WorkSetup: On-site at Round Lake, IL; full-time, exempt position.