Aaron Allen

Background

About Aaron Allen

Technical and Compliance Leader with 25 years experience in the biotech process industry. Experience includes process design engineering, production technical support, process equipment commissioning and qualification, process deviation support / root cause evaluation and corrective action generation, and inspection readiness for multiple jurisdictions.Leadership:Established and directed multiple MS & T teamsMember of multiple leadership teamsEstablished and led multiple global program initiatives Specialties:'Column Packing - Up to 2m columnsMicrobial and Mammalian Recombinant ProductsmRNA drug substance LNP and drug productDownstream Processing ExpertiseSuperPro DesignerProcess Monitoring initiativesTechnical:Process Design and Scale-UpTechnology TransferTechnical Representation for Regulatory Responses and Audits with FDA, TGA, MHRA, Health Canada, SwissMedic and other PIC/s membersProcess and cleaning validation SMEEquipment and facility designInvestigations and product impact assessments Qualified risk assessment facilitatorTechnical lead for multiple product submissions Compliance:Led Annex 1 gap assessments and development of mitigation actions across the networkProvided inspection readiness for new sites in Canada, UK, and AustraliaProvided technical representation in face to face meetings with MHRA and TGA