Tyra Bookhart

Technical Operations, Filtration Team

SOPs and Protocols

• Develop and/or revise Standard Operating Procedures (SOPs), to comply with industry, regulatory and site standards
• Draft and execute protocols for investigational, re-test, and sampling purposes to support manufacturing processes and prospective variations of the Human Papilloma Virus (HPV) vaccine

Sampling

• Lead buffer collection to assist in developmental and investigational changes in laboratory-scale chromatography, filtration, and reassembly processes involved in the downstream HPV manufacturing process
• Lead and schedule sample collections and shipping for HPV Purification, to assist with regulatory release testing, qualifications of Merck sites, development of next generation HPV vaccines, and other testing for research, stability, and qualifications
• Identify and support scheduling routine sample request improvements by supporting the creation of an alert system to ensure Center for Biologics Evaluation and Research (CBER) date is not missed
• Work with cross-functional teams to develop and improve manufacturing systems to support utilizing current good manufacturing practices (cGMPs), while maintaining and improving quality standards
• Corrective Actions/Preventative Actions
• Support deviation management and corrective/preventative actions to establish continuous improvement within the manufacturing process
• Create and support Kanban system for sterile assemblies to ensure efficiency during manufacturing process

Digitization

• Lead eSOP transition for HPV Purification to reduce paper used throughout manufacturing areas, to increase efficiency and compliance standards
• Identify and support MES updates for Solution Prep and Ultrafiltration 2 (UF2) (processing and filters), as well as inputting processing attributes in GLIMS to support CBER and Continued Process Verification (CPV)/Quality Notification (QN) analysis
• Lead Buffer MES updates in support of optimization of buffer processes within the PAS-X system

Ultrafiltration 2

• Lead and facilitate UF2 filter sieve testing, trend data on UF2 filter and process data for investigational purposes, resolve internal and external data request, and identify process improvements
• Support and lead projects for UF2 filter optimization to increase longevity of filter re-use
• Author troubleshooting procedures for filter testing and sampling
• Present technical information to new hires and regulatory counterparts.
• Conducted product training sessions for new associates.

Technical Operations, Robustness and Digitization Team

• Developed and implemented engineering strategies to improve production efficiency.
• Performed calculations and simulations to analyze performance data.
• Collaborated with cross-functional teams throughout the development process to ensure successful outcomes.
• Assisted in troubleshooting issues related to product design or manufacturing processes.
• Documented all engineering activities according to established procedures.
• Generated reports summarizing engineering results for internal review.
• Participated in team meetings to discuss project progress updates.
• Applied technical knowledge to help promote safe work environment and enhance customer satisfaction.
• Develop and/or revise Standard Operating Procedures (SOPs), Protocols, and Batch Sheets to comply with industry, regulatory and site standards
• Collect buffer samples to assist in developmental and investigational changes in laboratory-scale chromatography, filtration, and reassembly processes involved in the downstream Human Papilloma Virus (HPV) manufacturing process
• Work with cross-functional teams to develop and improve manufacturing systems to support utilizing current good manufacturing practices (cGMPs), while maintaining and improving quality standards
• Schedule and lead sample collections and shipping for HPV Purification, to assist with regulatory release testing, qualifications of Merck sites, development of next generation HPV vaccines, and other testing for research, stability, and qualifications
• Leading 8-step for data integrity (DI) related quality notifications (QNs), where the main goal is to ensure cGMPs and reduce DI related QNs throughout HPV Purification
• Led study to observe the durability of the schott bottle to test its ability to hold frozen material
• Point of contact for all document requests and escalations for HPV Purification to support revisions aligning with industry, regulatory and site standards
• Creating a robust system for document requests and escalations to ensure documents are being requested within its respective time period, as well as becoming effective during the respective wave date
• Support deviation management and corrective/preventative actions to establish continuous improvement within the manufacturing process
• Supported pre-qualification for transfer of filter testing to manufacturing execution system (MES)
• Present technical information regarding continuous improvement projects to senior leadership team.

• Reviewed patent applications for compliance with legal requirements and technical specifications.
• Evaluated the potential impact of proposed inventions on existing technology.
• Interpreted complex technical information from inventors in order to evaluate its relevance to the claims being examined.
• Collaborated with attorneys, scientists, engineers, and other experts during the examination process.
• Prepared detailed written reports summarizing findings and conclusions after each examination.
• Recommended whether a patent should be granted or denied based on evidence collected during the examination process.
• Advised applicants of any changes or modifications needed for their application to meet requirements.
• Communicated effectively with clients via phone, email, or in person meetings.
• Resolved difficult issues relating to patents under review through collaboration with team members.
• Prepare office actions to clearly evaluate and explain an applicant’s patent application
• Extensively search though earlier publications, technical literature, and online databases for US and foreign applications to make ensure applications are novel
• Discuss and negotiate with the applicant and/or patent attorney to resolve matters raised in the final report
• Ability to efficiently digest large volumes of scientific information, to make timely decisions regarding patentability of an application
• Identified relevant prior art to determine patentability of invention claims.

Technical Operations, Supplier Technical Integration

• Developed and implemented engineering strategies to improve production efficiency.
• Analyzed customer requirements to determine project scope and objectives.
• Assess vendor change notifications for the site to determine product, process, and regulatory impact
• Change Owner for supplier and internal changes to meet production and material release deadlines
• Work with cross-functional teams to develop and/or improve manufacturing systems to support utilizing cGMP for process equipment while maintaining and improving quality standards
• Responsible for handling material builds and qualifications to implement new use of materials and components on site
• Develop and revise Standard Operating Procedures (SOPs) to comply with industry, regulatory and site standards
• Connect with suppliers to ensure sustainable implementation of changes and relay vendor changes/recommendations to IPT
• Assist with training personnel of processes and systems
• Created safety and team tier board in order to have increased visibility of changes and safety around the site
• Implement corrective/preventive actions for existing equipment and manufacturing processes