WarrenDalker - Ultimate Professional

8+ years experience in pharmaceutcial manufacturing. Good communicator Team player Technical transfer and process development of ATMP, viral vector drug products and provide strategic standpoint for future scale-up of FDA approved commercial products • Source components, excipients and equipment as part of NPI, considering process suitability and material compatibility. Develop protocols for testing and validation of new equipment and consumables for use within sterile fill-finish • Develop manufacturing technical agreements and associated batch documentation as Subject Matter Expert (SME) for manufacturing and quality processes • Continuous client engagement and partnership, providing audit and regulatory support where required to support client submissions • Lean methodologies in continuous improvement initiatives. DMAIC, FiveWhy’s and Ishikawa tools to identify root causes and assess corrective actions within the Quality Management System (QMS) • Trending of department QMS, equipment downtime, and department training analysis • Ongoing review of excipient monograph’s to assess relevant testing needs for use of materials in clinical and commercial manufactures. Perform Risk Assessments and assess project compatibility • Collaborating with wider business to plan for introduction of regulatory updates as referenced in EU Pharmacopoeia GMP