Kimberly Discar
@kimberlydiscar
I deliver compliant global regulatory submissions and validated systems for biotech products.
United StatesWhat I'm looking for
At Santen, I support global regulatory submissions and systems, including end-to-end delivery of INDs and eCTD publishing for EU, Japan, and EAEU submissions.
I've contributed to five major marketing applications, including ownership of two FDA NDAs, publishing support for two PMDA NDAs and one EU MAA, and more than 100 eCTD sequences across 15+ applications.
I lead CSV and SDLC coordination for Veeva Vault RIM and Lorenz docuBridge, strengthen global governance through SOPs and training, and partner across Regulatory Affairs, Quality, Clinical, and CMC to deliver accurate, inspection-ready submissions.
Experience
Work history, roles, and key accomplishments
Executed end-to-end support for two IND submissions and directed integration of eight acquired products into Lorenz docuBridge. Harmonized submission processes across global regions and served as SDLC owner and CSV lead coordinator for regulatory systems.
Executed high-volume eCTD submissions to FDA and Health Canada, delivering over 30 health authority submissions within six months. Authored regulatory user guides and trained new team members on publishing processes.
Lab Assistant 1
Fornia BioSolutions
Jan 2019 - Dec 2019 (11 months)
Operated automated laboratory instrumentation within a regulated environment and prepared media, reagents, and buffers in accordance with SOPs. Maintained laboratory compliance through equipment cleaning, inventory management, and safety inspections.
Bioconjugation QC Technician
Biotium
Jan 2017 - Dec 2019 (2 years 11 months)
Managed high-throughput production of fluorescent antibody conjugates, executing 12+ bulk work orders weekly and improving productivity to 90% within one year. Performed antibody conjugation and QC testing to ensure product integrity.
Education
Degrees, certifications, and relevant coursework
California State University, Sacramento
Bachelor of Science, Biochemistry
Bachelor of Science in Biochemistry from California State University, Sacramento.
University of Manchester
Associate of Arts, Science and Quantitative Reasoning
Associate of Arts in Science and Quantitative Reasoning from the University of Manchester.
Solano Community College
Associate of Arts, Liberal Studies
Associate of Arts in Liberal Studies with a focus on Elementary Teacher Preparation from Solano Community College.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Salary expectations
Job categories
Skills
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