Karissa Hannon Email & Phone Number

Albany, New York Metropolitan Area

Albany, New York Metropolitan Area

• Coordinate cross-functional reviews for initial CTA packets, incoming queries, and subsequent CTA amendments, and annual reporting requirements• Facilitate kick off meetings with CROs• Track CTA submission and approval dates, incoming query and response dates, regulatory commitments and deliverables, as well as document version tracking• Serve as the prime regulatory contact with our CROs for continuity on process IMVT will utilize for CTA support and communication back to CRO any concerns or escalations needed• Review clinical documents in submission packets and serve as the POC for clinical documents for CROs• Develop and maintain CTA submission playbook/process in collaboration with Regulatory Affairs

Troy, Ny

• Manages multiple high visibility programs utilizing Supply Chain Operations order ticket systems and Project Management skills from the Drug Substance stage through the study starts throughout the world• Cross-functionally manages teams to work towards performance targets• Presents at large meetings that entail critical business items with executive level management• Ensures each Order Ticket’s timeline is adhered to with constant adapting to changing requirements

1 Global View Troy

• Owned and coordinated large scale projects and Class A Major Change Controls that introduced new high profile clinical molecules into the manufacturing space for the first time.• Utilized Project Management best practices to ensure project deliverables are met on high visibility programs• Ensures effective communication between 20+ departments for each project• Presented Changes Controls to various large meetings including those with executive management present.• Determined risk and completed Quality Risk Assessments for each project.• Organized, ran, and provided minutes for Cross Functional Change Control Lessons Learned Meetings

• Successfully transitioned from temporary to permanent role with exceptional performance (Aug 2015 - Jun 2016).• Streamlined communication with lab managers to efficiently track and allocate samples, enhancing operational workflow.• Devised comprehensive slide decks for executive meetings, ensuring clear communication of project updates and metrics.• Regularly facilitated departmental meetings, fostering a collaborative environment in the Quality Control (QC) team.• Implemented strategic organization of lab sample queues, optimizing sample distribution across departments.• Proficiently utilized Excel to manage and manipulate data, enhancing data interpretation and decision-making with the use of equations and macros.• Developed and sustained key Departmental Metrics, providing valuable insight into performance and efficiency.• Played a significant role in the Phoenix (Drumbeat) initiative project, contributing to backlog reduction efforts.• Effectively collaborated across various functional teams, ensuring timely completion of deliverables and upholding high standards of project execution.

Potsdam, Ny

- Assisted with projects for Student Life within the Student Success Center- Guided students with their needs ranging from directions to withdrawals

Master Of Business Administration - Mba, Logistics, Materials, And Supply Chain Management

Double concentration in Supply Chain and Analytics

Biology (Ba), Biology, General

Activities and Societies: Women's Group Ambassador's program Student Advisory Board Mentoring Teaching Assistant of Freshman Seminar.

Master Of Science - Ms, Business Analytics