Dr. Robert Eifler

Lead in a matrix; Manage and assess all material related process changes globally; Plan and execute MQ packages acc. to regulatory guidelines; Own E&L and CCI programs; Support CMOs, internal projects and local facilities through material’s lifecycle (select, implement, qualify, submission, change management); Strengthen relationship with supply chain and internal customers; Maintain knowledge of standards and literature (BPSA, BPOG, PDA), share knowledge with global network and apply it to procedures

Lead and inspire team (6-8) of Clean Validation and PPQ experts to develop and implement validation strategies for investigational and commercial drug products. Provide coaching, on-the-job training, resource planning and management through change. Facilitate communication with strategic partners, drive continuous improvement, participate in audits, support licensure and establish a bench-scale lab for clean processes. Act as SME and rep. to harmonize best-practices across Shire acc. to industry standards.

Implement validation requirements according to internal and external guidelines and provide GMP support for investigational and commercial products including process transfer and process, lifetime (chromatography resins and UFDF membranes) and transport validation using QbD principles (RACT, PFMEA). Conduct quality system and validation training, provide oversight for change management and non-conformancy reporting, participate in audits, support licensure and serve as SME for process validation and MQ.

Acting study director responsible for the study design, coordination and execution, resource management, donor recruitment, development of system and methods, performing cell and molecular biology techniques, data analysis and interpretation and communication of results.

Characterized and mitigated field failures, maintained product compliance, performed process development and transfer to production, equipment qualification, process validation and student mentorship.