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

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.

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.
• 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

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.
• 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

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.

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.

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.

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.

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)-.