Eunah Choi

• Provide Quality oversight of Design Characterization, Verification, Validation and technology transfer (design transfer) activities associated with commercialization of Combination Product and clinical product lifecycle management ensuring compliance with regulations.
• Provide Quality oversight of change control records and deviation records.
• Work multi-functionally with individual and project teams (supply chain, regulatory, process development, program/program managers, corporate) to ensure success of product commercialization.
• Responsible for maintenance of Design History files, Control Plans and Design Traceability Matrix.

Key Achievements:

• Streamlined design transfer documentation strategy for one of high priority product and increased efficiency by 30%.

• Led cross-functional teams to plan and execute high complexity NPI projects supporting pre-clinical, clinical, and commercial advancement studies and initiatives.
• Served as effective New Product/Process Introduction (NPI) project manager/technical liaison for Final Drug Product NPI Technology Transfers (TT) at multiple clinical manufacturing facilities.
• Managed end-to-end aspects of multiple NPI projects demonstrating high right first time success by quickly identifying risks, mobilizing appropriate stakeholders to develop mitigation plans and ensure resolution.
• Developed business cases to facilitate executive decision making on process improvement projects.
• Led multiple productivity improvement and lean concept initiatives to standardize and improve efficiency for NPI business operations.

Key Achievements:

• Successfully implemented Amgen's first owned Auto-Injector device manufacturing process for clinical product launch.
• Successfully integrated several strategic objectives and implemented new processes and tools that represent first major advancement with clinical packaging/labeling configuration matrix since 2015.
• Fostered new workstream meeting structure and tool for management of multi-site Clinical TT NPI project which increased efficiency of project implementation.

• Performed Drug Product Filling/Formulation manufacturing tasks under Current Good Manufacturing Practice (cGMP) including setup and operation of filler/isolator.
• Owned deviation and change control records.
• Led formulation group and managed process schedule/finite schedule for unit operations and resources. Trained new staff on various manufacturing activities.

Key Achievements:

• Led Single Use System (SUS) project including development and successfully implemented SUS formulation buffer vessel, drug product pool vessel and filtration assembly.
• Established as Subject Matter Expert (SME) in Drug Product formulation, filtration and filling processes.

• Collaborated with clients to develop manufacturing process ensuring process requirements are being met.
• Authored technical documents (study protocols and reports, Standard Operating Procedures, Out of specification investigation reports).
• Performed qualification of various manufacturing equipment and validation activities (Steam In Place, Clean In Place, Sterilization validation) and successfully led protein Filtration/Tangential Flow Filtration/Column Chromatography projects under cGMP.