Emma Trivella Email & Phone Number

▪ Coordinating the design and execution of cross-functional CMC and Clinical Supply project plans from early clinical development to commercial launch for clients and alliance partners.▪ Maintains frequent communication with the cross-functional project team members and key internal stakeholders so that all parties are aware of current project status, issues, contingencies, and milestones.▪ Identify critical path, risks and impediments to successful development and drives the identification and development of solutions to mitigate these risks.▪ Leading team meetings and ensuring that clear agendas are set, and actions and decisions are documented, communicated, and committed to, enabling timeline achievement▪ Develop work scope documentation (RFPs) and evaluation of quotes for vendor section per the program needs▪ Managing and supporting clinical packaging, clinical supply, and clinical shipment activities

Responsible for managing all new and current corporate accounts with HUBB UCS and HUBB AGRO ▪ Managing daily tasks supporting all account with technical support and development of product and training▪ Develop relationships with decision makers (technical and economic) in geographic area▪ Maximize sales with targets set by the company ▪ Developing in process guidelines for user and internal team, training videos and standard procedures for Agro build-in design ▪ Conducting testing to new software feature, updates and service of product launch ▪ Providing weekly technical inputs, on software troubleshooting and Agro greenhouses development for business continuity▪ Working cooperatively with various departments, engineering, sales, IT and suppliers, to ensure a continuous product effectiveness

Cincinnati, Ohio, Us

 Lead and manage packaging technical readiness for new initiatives and changes including productcompatibility, package integrity, functionality testing and supplier developed or stock packaging. Conduct new packaging testing and on site qualifications of primary and secondary packagefilling and assembly at Contract Manufacturers Provide technical input for the manufacturing sites and troubleshooting of technical issues onpackaging processes and materials to ensure quality and business continuity. Development and ownership of all packaging documents for chemistry and secondary and tertiarylevel packaging for razors and adjacencies – including but not limited to; technical drawings,packaging instructions, pallet patterns and packaging masters. Qualifications of new packages, materials and packaging processes to eliminate losses Collaborate with procurement for material qualification and quality environment Provide development and execution of product packaging strategies, work closely with internalfunctions within the operations, sales, marketing and project management teams, managing newpacking capability development, cost saving initiatives, and supply chain sustainability.

Minneapolis, Mn, Us

Managed Territory Sale representative working directly with physicians and patients to increase the penetration of Metronic Heartware products. ▪ Meeting clients and potentially new customers to present and demonstrate Metronic medical device products to review their benefits ▪ Driving sales of Metronic products through regular contact/visits to medical specialist providing clinical information, product information and advice so that the health care professional recommends and prescribes our products▪ Educate medical staff on the use and benefits of medical devices. Provide product demonstrations and support▪ Ensure smooth ordering at all accounts (new and existing)▪ Communicate between sales, marketing, and support teams to improve customer experience▪ Collect, analyze, and present field sales data and to assist with strategy planning and implementation

Minneapolis, Mn, Us

Managed packaging and labeling related projects and activities for sterile and non-sterile products. Developed packaging, documentation, labeling and processes for current and new designed or modified packaging, products, processes and materials▪ Designed and coordinated standard engineering tests and experiments for new product development▪ Worked along with Supplier forecast planning, validation activities, risk management and improvements to components▪ Ensured packaging and labeling is in compliance with regulatory, and specification requirements and standards▪ Supported the validation of packaging equipment and labeling equipment to include IQ, OQ, PQ▪ Supported value stream manufacturing teams for packaging and labeling projects ▪ Performed and troubleshooting on new or existing packages/documentation/ products/process problems as related to design, material, or process▪ Generated packaging-related documentation including specifications, test plans and reports, and other product/process development documents▪ Worked cooperatively with various departments, divisions, and suppliers, to ensure an improved, practical, and consistent approach to packaging/labeling

Fort Lauderdale, Florida, Us

Responsible for gathering historical data, execution of characterization studies and validation protocols. Performing Gap Assessment as part of a remediation project to conform with Regulatory Compliance Generating and executing Validation Protocols to ensure processes demonstrated reliability and repeatability and implementing new validation processes to the system Designing Test Method Procedures for Medical Device Components Gathering validation inputs for equipment settings and product specification  Authoring Validation Protocols and Reports

Cambridge, Ma, Us

Responsible for managing and supporting contract manufacturing organizations (CMOs) for commercial packaging and labeling operations and commercial manufacturing for oncology commercial drug product(s) in the US market- Serving as primary manager for packaging CMOs for operational and business relationship activities - Authoring and ensuring timely resolutions of deviations, investigations and change controls associated with the packaging of finished goods and manufacturing drug products- Validating /qualifying finished good commercial packaging process for suite, equipment changes and cold chain - Managing the implementation and validation of the serialization system to our packaging process line- Revising packaging and labeling material components for commercial drug products as well as all associated documents for packaging processes for regulatory submissions- Managing the implementation of the Global Electronic Artwork Management System to all associated departments at the Takeda Boston campus - Authoring pertinent SOP’s, manufacturing process instructions and validation/qualification reports for the commercial manufacturing, packaging and cold chain - Monitoring and identifying key process and business performance indicators for each of the sites and implement improvements as appropriate- Participating during inspections and audits at the commercial packaging sites- Maintaining inventory levels based on forecasted schedule activities and commercial demand- Leading bi-weekly teleconferences with two packaging sites focused on packaging production, ongoing projects and pending action items- Coordinating onsite business commercial meetings - Supporting and monitoring commercial manufacturing production and validation process - Authoring excursions associated with the manufacturing production - Monitoring routinely commercial manufacturing activities

Cambridge, Ma, Us

Responsible for coordinating and supporting all commercial supply operations manufacturing excursions and manufacturing process activities - Authored and ensured timely resolutions of deviations, investigations and change controls associated with all commercial manufacturing drug product sites - Assigned as Supply Operations representative for CMO weekly meetings, on site business meetings and based need routine manufacturing activities - Created and maintained a database for all commercial drug products manufacturing CMOs and identified critical process parameters for better process capabilities- Presented trending data at quarterly metrics meetings- Served as a point of contact for alliance partner for all documentation link to commercial drug product- Supported change control review board for alliance partner CMO- Managed and coordinated new change controls for alliance partner to ensure deadlines and to maintain turnaround times for approval- Maintained change control summary reports for trending of approvals and turnaround times for business meeting

Tokyo, Jp, Jp

Responsible for evaluating new technologies and practices to improve commercial production processes- Supported root cause analysis for process discrepancies and quality investigations - Collaborated with team members for technology transfers to support clinical and commercial production. Assisted in regulatory inspections and filings- Performed data analysis and execution of experiments aimed to reduce recurring deviations- Analyzed product processes to improve robustness/capacity/productivity, and increased safety and compliance- Supported weekly meetings with other departments to collect and provide detailed information on process improvements and data analysis results- Assisted in the lab design and maintained an orderly purchase of materials and supplies according to established budget

Tokyo, Jp, Jp

Responsible for performing routine manufacturing operations for the production of clinical and commercial products.- Authored and edited SOP's along with routine review of process manufacturing documentation- Maintained production records and clean room environment to comply with regulatory requirements and current Good Manufacturing Practice (cGMP)- Provided training and guidance to new manufacturing employees to ensure compliance with GMP's - Identified and reported potential discrepancies in documentation to avoid new or recurring deviations