Specialist II, PK Sample Management (BioAnalytical Systems Analyst)

Role: Support global PK and BioAnalytical operations by managing sample and vendor logistics, tracking PK samples, and ensuring regulatory compliance. Responsibilities: oversee shipment coordination from clinical sites to labs, generate PK sample reports, support long-term storage, assist in SOP updates, and facilitate communication with vendors and internal teams. Requirements: high school diploma with 5+ years of related experience or bachelor’s degree with 3+ years; strong organizational, communication, and documentation skills; proficiency in Microsoft Office; familiarity with GxP, drug development, and PK sample management. Preferred: additional PK logistics expertise, knowledge of IRT systems, and understanding of US/EU regulations. High-Value: biopharma clinical PK operations, sample tracking, regulatory compliance, and cross-functional collaboration. WorkSetup: not specified; likely hybrid or on-site based on company location.