Hank Saye Email & Phone Number

Melbourne, Victoria, Au

Experienced in leading critical Serialization business processes, I serve as the go-to Subject Matter Expert (SME) for campaign readiness, incident resolution, GS1 standards, and regulatory management. With a strong focus on continuous improvement, I drive system enhancements across SAP ECC and data analytics, optimizing supply chain performance.In addition to overseeing serialization implementation projects, I support packaging and labeling initiatives, ensuring compliance and operational efficiency. As a key player in the global Center of Excellence, I contribute to harmonizing supply chain processes, enabling better control and process improvement across planning, logistics, and warehouse functions.With a dual focus on project management and technical leadership, I take the initiative to maintain and enhance decision support models, fostering innovation and productivity. I also lead system control projects, such as SAP ECC master data harmonization, while spearheading business process improvements within logistics, planning, and contract manufacturing.

Melbourne, Victoria, Au

• Process Expert: Owner / Author / Approver of Standard Operating Procedures (SOPs), Batch Records, and Training Documents. Investigate deviations, determine impact, and own effective correction action palns. Provide real time, on the floor, support of manufacturing during unscheduled downtimes. Provide consultation for facility expansion team on equipment and process design. Audit Contract Manufacturing Organizations, generate third-party complaints for defective materials, and assess vendor change notification. Participate in regulatory audits and assist with responses to regulatory observations.• Inspection / Packaging Suite Team Lead: Serve as liaison between manufacturing and site support teams, including Quality Assurance, Automation, Engineering/Maintenance, Validation, and the Deviation team. Identify and lead seasonal projects to increase efficiency, reduce waste, and increase capacity to meet site goals and increasing market commitments. • Key Projects: Implementation of Serialization - enroll equipment and materials in order to ensure on-time delivery of reliable automated serialization system. Work with cross-functional groups to project plan, test and validate Optel Serialization for distribution of commercial projects to global markets. Train operators on equipment and procedural changes to improve on the floor troubleshooting and expertise.

Melbourne, Victoria, Au

• Instrumental in the licensure of the Vaccine Manufacturing Facilities (VMF102 and VMF101) via FDA license authoring opportunities, lyophilization and vial freezing development, automation (DeltaV) and batch record (MES) support and subject matter expertise (SME) in capping and inspection, including aiding in quality notifications, deviations, investigations and regulatory compliance. • Performing factory acceptance testing, IQ, OQ and PQ of critical processing equipment and tuning of machines to develop CQA's, CPPs and PCLs; along with increasing detection of true rejects, lowering false reject rates, increasing profit and realizing >$3.4M in savings.• Collaborated with the Durham QO (Quality Operations) Lab to introduce the plant site as a new test site for potency, moisture, stability and releasing testing for ZOSTAVAX® 4C for the Merck network.

• Aiding in the technical transfer of the M-M-R®II and VARIVAX® III franchises from and engineering batches through process performance qualification to full-scale commercial production to supply global demands for the vaccine (annual output of >18M doses).• Lead process development activities for ZOSTAVAX® 4C, through time-pressure filling and dose optimization, performance qualifications of the Loading Accumulation Table (LAT) system and Automated Inspection Machines (AIMs), sample plan evaluation and implementation of a product specific glycol skid to stabilize temperature and potency for the vaccine. • Devised automation change controls for product recipes, analyzed complex dilution models to evaluate bulk vaccine usage and conservation, executed temperature mapping in controlled-classified spaces, developed pilot lab-scale experiments to achieve right-first-time Product Performance Qualifications (PPQs) for multiple vaccine franchises and obtain World Class Supplier status.

• Primary role in identifying, and isolating adult stem cells for use in proprietary regenerative cell therapy Phase I/II clinical trial applications targeting significant unmet medical needs by cellular processing and advanced sorting techniques.• Responsible for the technical advancement of a high speed cell sorting platform, modification to complex fluidic components and adaptation of electrical mechanisms to suit the specific needs of the manufacturing staff and to standardize work flow.• Troubleshoot and service complex machinery including: computer controlled flow cytometers, cells sorters, system networked environmental monitored devices and other basic laboratory equipment.

• Extensive work in cGMP validated and qualified clean room environments, cGLP qualified laboratories, media fills and process, operator and equipment qualifications for both the FDA and European Union regulatory agencies.• Research and development procedures with critical endpoint data for use in IND submission to the FDA in the fields of murine research, aggregation studies, various comparisons, stability, potency, sterility validation and culture analysis.• Composing documentation for laboratory facility standard operating procedures, production batch records, validation procedures and reports, specification sheets, change controls, deviation reports, CAPAs and R&D laboratory write-ups.

Chapel Hill, Nc, Us

• Collaborated with Dr. Bob Dennis and a small team in the creation of a small vehicle that is controlled wirelessly using biopotentials from the body. Using specific muscle movements, signal processing and software programming, we were able to control a vehicle we manufactured through a small course.• Worked with Dr. Christy Redmon on data acquisition for superconductors. Using Labview software, an accurate reading of a thermocouple voltage was discovered, which was converted to temperature in order to find the critical temperature of the experimental superconductor.• Invented a method for removing dissolved oxygen from water with a small team, and under the supervision of Dr. Paul Dayton. • Creation of a small rotating bioreactor. The device is designed to hold and culture different types of tissues.

• In charge of scheduling and opening and closing the facility• Oversaw all chemical balances• Leader for staff and Special Olympic events

Bs-Biomedical Engineering

Education record