Ashley S.
About Ashley S.
Ashley S. is a Business Operations Manager at Kite Pharma, where she oversees a $21.7 million budget and manages contract deliverables for API method development. With a background in chemistry and extensive experience in quality control and project management, she has contributed to FDA approval processes and leads multiple operational councils.
Work at Kite Pharma
Ashley S. has served as the Business Operations Manager at Kite Pharma since 2020. In this role, she manages the contract and deliverables for API method development and transfer to CMO. Ashley ensures that all Chemistry, Manufacturing, and Controls (CMC) documentation is provided for Dyve's FDA approval of the Investigational New Drug (IND) for Phase 2. She oversees a budget of $21.7 million and maintains Global Quality Performance Management data, including key performance indicators (KPIs) and annual goals.
Education and Expertise
Ashley S. holds a Bachelor of Science (BS) in Chemistry from California State University Channel Islands, where she studied from 2011 to 2013. She also completed a Project Management Certificate at UCLA Extension from 2021 to 2022. Currently, she is pursuing Project Management Professional (PMP) Certification through coursework at UCLA Extension, a program recognized by the Project Management Institute (PMI).
Background
Prior to her current role, Ashley S. worked in various positions within the biotechnology and education sectors. She served as a Senior Scientist at Eurofins Lancaster Laboratories from 2015 to 2018 and as a Product and Supply Chain Manager at Dyve Biosciences from 2018 to 2020. Earlier in her career, she held roles as a Quality Control Analyst at Stellar Biotechnologies, Inc. and as a Teaching Assistant and Tutor at California State University Channel Islands.
Achievements
Ashley S. played a critical role in reviewing the entire IND prior to submission at Dyve Biosciences, which helped prevent errors and omissions, leading to FDA approval. She also served as Program Manager for a First-In-Human (FIH) manufacturing project, successfully delivering a personalized product for a baby. Additionally, she leads the operating rhythm for multiple councils and committees at Kite Pharma, including the Global Quality Control Council and KLIMS Steering Committee.
Community Involvement
Ashley S. actively engages with her community through her role as Board Secretary for the CSUCI Alumni Executive Board. In this capacity, she is responsible for keeping meeting minutes and maintaining the membership list. She enjoys networking and mentoring alumni and students in their career paths, contributing to the professional development of others.