Ashley Horn
Lithia,FL
Summary
Accomplished leader with 12+ years of demonstrated success in the healthcare and biotechnology industries, specializing in clinical and commercial operations across diverse therapeutic areas and disease states. Skilled in effective communication at all organizational levels, offering supportive leadership and strategic guidance to cross-functional teams. Known for exceptional problem-solving abilities, with a proven track record of excellence in business operations, clinical and commercial launch, and strategic planning.
Overview
12
12
years of professional experience
Work History
Associate Director, Gene Therapy Operations - Program Lead, Lyfgenia
bluebird bio
09.2023 - Current
- Promoted to Associate Director for outstanding performance and leadership in gene therapy operations, following successful tenure as Sr. Manager overseeing Zynteglo and Skysona programs
- Develop and implement operational strategies, procedures and timelines to support the successful launch and execution of 3 commercial gene therapies: Zynteglo, Skysona and Lyfgenia
- Lead the gene therapy operations team in managing day-to-day patient logistics from enrollment through infusion across 50+ qualified treatment centers, fostering a culture of continuous improvement, innovation, and accountability
- Manage communication with treatment center care teams to provide support, patient product updates and guidance throughout the patient journey
- Oversee the logistics and strategic approach for 80+ clinical and commercial time and temperature sensitive shipments, ensuring safe and on-time deliveries to the Contracted Manufacturer Organization (CMO) and/or Qualified Treatment Center (QTC) through lane mapping, mode of transportation, tracking and escalations for product shipments
- Manage a transportation budget exceeding $4.0 million for HPC-A and drug product shipments
- Played a key role in driving operational excellence and strategic alignment with corporate goals for drug product release and shipments across all therapies in collaboration with Quality Control and Quality Assurance
- Develop tools for tracking key performance indicators (KPIs) and data reporting to the executive leadership team
- Collaborate with key internal and external stakeholders including manufacturing, CMC, finance, channel strategy, quality, vendors, treatment centers and commercial field teams to ensure a positive partnership and a seamless clinical and commercial gene therapy product execution
Associate Director, Cellular Products & Logistics
Medeor Therapeutics, Inc.
01.2019 - 01.2022
- Promoted from Senior Apheresis Manager to Associate Director for exceptional leadership and performance in driving vein-to-vein logistics and planning for Phase II and Phase III clinical trials, while effectively managing clinical operations and overseeing time-sensitive product shipments
- Implemented vein-to-vein logistics and planning strategies for 4 Phase II and Phase III cell therapy/kidney transplant clinical trials, ensuring seamless coordination and timely execution
- Managed escalation management for the clinical operations team, optimizing response times and resolution strategies for operational challenges
- Developed and delivered comprehensive apheresis GxP training materials to clinical sites, enhancing staff competence and compliance with industry standards
- Oversaw 70+ time and temperature-sensitive product shipments, identifying risks and implementing mitigation strategies to ensure product integrity and timely delivery
- Led cross-departmental coordination of project deliverables, fostering collaboration and ensuring project milestones were met on time
- Provided on-site technical support during HPC-A collections, packing, and infusions at clinical sites across the US and Canada, ensuring procedural adherence and quality control
- Supervised a team of clinical research associates in managing subject journey activities, ensuring protocol compliance and efficient site operations
- Collaborated with key stakeholders including CMC/Biopharmaceutical Operations, Quality Assurance, CMOs, and couriers to manage investigational product disposition and shipment logistics
- Developed and delivered training programs for clinical sites and CROs, ensuring adherence to FDA, AABB, FACT, GMP, and GCP standards and regulations
- Presented protocol and apheresis procedures at Site Initiation Visits and Principal Investigator Meetings, ensuring alignment with study requirements
- Communicated effectively with leadership and cross-functional teams to report on deliverables, key performance indicators, risks, and mitigation plans for successful project outcomes
- Developed SOPs, source documents, and manuals for apheresis starting material and cryopreserved product shipments, ensuring compliance with regulatory standards and best practices
Blood Center Technician, Medical Assistant III – Contractor
Stanford Blood Center/Stanford Health Care
08.2020 - 06.2021
- Conducted COVID-19 convalescent plasma and platelet collections, adhering to stringent guidelines and protocols
- Evaluated donor eligibility based on COVID-19 convalescent plasma and platelet donor regulations, assessing donor medical history and performing physical examinations including blood pressure, weight, and pulse measurements
- Managed and addressed blood donor reactions, such as citrate reactions, hypovolemia, vasovagal reactions, and venous access complications, ensuring donor safety and well-being throughout the collection process
Apheresis Coordinator
Stanford Blood Center/Stanford Health Care
05.2017 - 02.2018
- Implemented the utilization of 8 Spectra Optia devices for HPC-A collections, enhancing efficiency and quality of apheresis procedures
- Supported validation processes and provided internal training for Mononuclear Cell (MNC) Collections and Granulocyte (PMN) Collections
- Enhanced the apheresis program by increasing staffing levels by 66%, successfully onboarding and training Registered Nurses and Medical Technicians in apheresis technology to meet operational demands
- Managed day-to-day operations of the apheresis department, conducting staff competency assessments, overseeing workflow, and ensuring staff had necessary resources, system access, and training for optimal performance
- Evaluated staff performance, provided guidance on professional development, and actively participated in the hiring and selection process for apheresis staff to maintain a skilled and efficient team
- Conducted statistical analysis of apheresis blood collections to identify areas for improvement, utilizing data-driven insights to troubleshoot technology issues and address complex challenges within the department
- Developed, maintained, and updated Standard Operating Procedures (SOPs) related to apheresis technology and blood collection compliance, ensuring adherence to industry standards and regulatory requirements
- Collaborated with leadership to optimize the apheresis program, managing and evaluating SOPs to enhance operational efficiency and ensure compliance with best practices and guidelines
Lead Training Specialist
Stanford Blood Center/Stanford Health Care
06.2015 - 05.2017
- Designed and implemented a comprehensive onboard training program for over 50 nurses and medical assistants, establishing a field team of 15 educators, mentors, and preceptors to support ongoing education and professional development
- Created training materials and tools to enhance employee knowledge in blood collections and venipuncture techniques, ensuring proficiency and adherence to best practices in the field
- Supervised trainees' day-to-day activities, conducted staff competency evaluations, and provided coaching, feedback, corrective action, and retraining as necessary to maintain high performance standards
- Monitored training effectiveness through observation and metrics analysis
- Offered guidance and oversight during blood donation complications, including citrate reactions, hypovolemia, vasovagal reactions, and venous access issues, serving as a resource and troubleshooter for technical challenges in whole blood and apheresis blood collections
- Led and supported operational implementations, process improvements, and procedural changes to align with operational requirements and enhance efficiency
- Collaborated with Donor Services management, Quality & Regulatory Assurance, Medical Directors, and external vendors to ensure training programs met regulatory standards and operational goals
- Maintained training records and documentation by utilizing Excel spreadsheets to track and organize relevant training data
Blood Center Technician/Apheresis Operator, I/II/III
Stanford Blood Center/Stanford University, School of Medicine
12.2012 - 06.2015
- Evaluated donor eligibility by conducting thorough assessments of donor medical history and physical parameters such as blood pressure, weight, and pulse to ensure suitability for blood donations and related samples
- Proficiently performed capillary sticks and obtained venous access through peripheral venipuncture for a range of blood collection procedures including whole blood, double red cell, platelet, and plasma donations
- Managed and addressed blood donor reactions, including citrate reactions, hypovolemia, vasovagal reactions, and venous access complications, with a focus on prompt and effective intervention
- Demonstrated exceptional phlebotomy skills and advanced proficiency in venipuncture techniques, ensuring precise and comfortable blood collection experiences for donors
- Supported donor room preparations, conducted quality control procedures, maintained accurate record documentation, and implemented sterilization protocols to uphold the highest standards of safety and hygiene in the blood collection process
Education
Bachelor of Science - Business Administration with a concentration in Marketing
San Jose State University
San Jose, CASkills
- Performance evaluations
- Onboarding and training
- Diversity and inclusion initiatives
- Decision-making
Awards & Nominations
bluebird bio Patient Supply Employee of the Year: Awarded for outstanding performance in 2024
bluebird bio Patient Supply Employee of the Year: Awarded for outstanding performance in 2023
Stanford Blood Center / Stanford Health Care Collections Change Agent Champion: Selected as a liaison between staff and management to represent the donor collections department, fostering communication and collaboration.
Stanford Blood Center / Stanford Health Care Change Agent Champion: Appointed as an ambassador of Stanford Blood Center employees, advocating for employee engagement and positive workplace culture.
Stanford Blood Center / Stanford Health Care Employee Engagement Champion: Recognized by the executive team for creating a supportive and engaging employee experience, contributing to a positive work environment and team cohesion.
Timeline
Associate Director, Gene Therapy Operations - Program Lead, Lyfgenia
bluebird bio
09.2023 - Current
Blood Center Technician, Medical Assistant III – Contractor
Stanford Blood Center/Stanford Health Care
08.2020 - 06.2021
Associate Director, Cellular Products & Logistics
Medeor Therapeutics, Inc.
01.2019 - 01.2022
Apheresis Coordinator
Stanford Blood Center/Stanford Health Care
05.2017 - 02.2018
Lead Training Specialist
Stanford Blood Center/Stanford Health Care
06.2015 - 05.2017
Blood Center Technician/Apheresis Operator, I/II/III
Stanford Blood Center/Stanford University, School of Medicine
12.2012 - 06.2015
Bachelor of Science - Business Administration with a concentration in Marketing
San Jose State University
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