Ian Owens Email & Phone Number

United States

Provided data management, analytics, and validation program management consulting services to a clinical phase CAR T cell therapy and gene therapy biotechnology organization including but not limited to:-Validation Lead for Commissioning, Qualification, and Validation activities ensuring the manufacturing facility is in compliance to manufacture clinical trial materials.-Validation Lead and Project Manager for commissioning, qualification, validation of CFR Part 11 compliant… Show more Provided data management, analytics, and validation program management consulting services to a clinical phase CAR T cell therapy and gene therapy biotechnology organization including but not limited to:-Validation Lead for Commissioning, Qualification, and Validation activities ensuring the manufacturing facility is in compliance to manufacture clinical trial materials.-Validation Lead and Project Manager for commissioning, qualification, validation of CFR Part 11 compliant software such as Instant GMP-INV, Blue Mountain Regulatory Asset Manager, Skyland Data Analytics, Vaisala Enviromental Monitoring, and IDBS E-Workbook.-Serve as system administrator and subject matter expert for Skyland Analytics PIMS at a CAR T cell therapy biotechnology organization to support company-wide scale out of the 21 CFR Part 11 compliant solution. Show less

Fremont, North Carolina, United States

Provided data management, analytics, and validation consulting services to a clinical phase CAR T cell therapy and gene therapy biotechnology organization including but not limited to:-Validation Lead for the decommissioning project of the Validation Program during Divesture. -Validation Lead and Project Manager for phase-appropriate qualification and validation efforts for testing processes and ancillary systems at the PBI HQ Facility. -Validation Lead and Project Manager for… Show more Provided data management, analytics, and validation consulting services to a clinical phase CAR T cell therapy and gene therapy biotechnology organization including but not limited to:-Validation Lead for the decommissioning project of the Validation Program during Divesture. -Validation Lead and Project Manager for phase-appropriate qualification and validation efforts for testing processes and ancillary systems at the PBI HQ Facility. -Validation Lead and Project Manager for commissioning, qualification, and validation for CFR Part 11 compliant software such as Adobe E-signature Platform, and Box GMP. -Serve as system administrator and subject matter expert for Skyland Analytics PIMS at a CAR T cell therapy biotechnology organization to support company-wide scale out of the 21 CFR Part 11 compliant solution.- Remediate people-dependent or undefined data management workflows through value stream mapping and process improvement delivery.- Create new sustainable data management workflows and procedures to ensure manufacturing in-process, release, stability, and characterization analytical data is electronically tracked with a focus on data integrity.-Create automated data trending dashboards per customer requirements.-Various Equipment Qualifications for AAV processing suite, CAR T processing suite, and QC Lab. -Controlled temperature unit and analytical spreadsheet validation execution.-Data management and validation project management in smartsheet project management software.-Authoring SOPs, protocols, reports, and discrepancy investigations using root cause analysis tools.- Project Manager over project to improve aseptic process simulation and gowning/aseptic qualification business processes with the goal of delivering an improved program and processes. Show less

-Efficiently manage a caseload of 150-200 patients, address payer issues, and resolve escalated issues. - Partner with aligned pharmacies to implement strategies aimed at reducing cycle time and increase conversion through data analysis and reporting. - Research and monitor insurance trends and partner with specialty pharmacies to help remove non-clinical barriers. - Collaborate with cross functional teams to plan, implement, review, and analyze Change Management plans. -… Show more -Efficiently manage a caseload of 150-200 patients, address payer issues, and resolve escalated issues. - Partner with aligned pharmacies to implement strategies aimed at reducing cycle time and increase conversion through data analysis and reporting. - Research and monitor insurance trends and partner with specialty pharmacies to help remove non-clinical barriers. - Collaborate with cross functional teams to plan, implement, review, and analyze Change Management plans. - Identify ways to streamline organizational processes, improve data integrity, and generate more revenues.- Assist with preparing operational reports and ensuring the accuracy of all records and documentation. -Liaison between Pharmacy Operations and internal Field sales force and Reimbursement Access Managers. -Serve in leadership capacity by representing the Product Procurement Team in Organizational/operations meetings, and participate in initiatives designed to improve coverage while team members are out of office to ensure Work in Progress gets completed. - Presented with multiple awards (customer impact award, Presidents award), and exceeded all performance metrics year after year. Show less

- Worked as regional case manager supporting five therapies. Worked with the field sales force team and managing the relationships of the Neurology Medical Offices in my territory. Completed data analytics for the territory and produced reports for operations and regional sales teams. - Effectively led disposition reports and conference calls to assist with removing non-clinical barriers for patients. - Processed and organized data, maintained records, monitored compliance, and… Show more - Worked as regional case manager supporting five therapies. Worked with the field sales force team and managing the relationships of the Neurology Medical Offices in my territory. Completed data analytics for the territory and produced reports for operations and regional sales teams. - Effectively led disposition reports and conference calls to assist with removing non-clinical barriers for patients. - Processed and organized data, maintained records, monitored compliance, and reported adverse events. - Communicated effectively with patients, providers, specialty pharmacies, and various financial partners. - Responded to inquiries about products/services, and helped ensure overall satisfaction. - Provided educational information on Multiple Sclerosis (MS), Crohn’s disease, and other drug therapies. - Worked collaboratively with regional case managers, therapy support coordinators, and other key staff in cross functional teams. Show less