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.

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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.
• 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.

• 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.
• 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.
• 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.
• 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.

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.
• 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.
• 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