Isam Hararah
Director of Pre-Pivotal Biologics Cell Culture Process Development at Gilead | Bioprocess CMC Specialist | Biotech, Pharma
- Role
- Director of Pre-pivotal Biologics Cell Culture Process Development at Gilead Sciences
- Location
- Daly City, CA, US
- LinkedIn followers
- 500 followers
About Isam Hararah
With extensive bioprocess development and manufacturing experience in the biotechnology industry, I am a CMC specialist who has provided technical expertise and leadership for over 30 biologics [including bispecific, complex, bioconjugate formats] and cell & gene therapy portfolio projects. These projects span pre-clinical through commercial stages, including in-licensed and outsourced programs, line extensions, and the development, global tech transfer, and initial licensure of the cell culture processes for Tecentriq®, Ocrevus®, Rituxan Hycela®, Phesgo®, and Lunsumio®.Currently, I am the Director of Cell Culture Process Development for Pre-Pivotal Biologics at Gilead, and it’s my privilege to lead teams of bioprocess scientists and engineers who feel the connection between the work they do to advance our early-stage therapeutics portfolio and the mission of helping improve the lives of patients.I am committed to building high-performing teams, with a focus on fostering inclusion and cohesion to harness the collective energy and potential of all members to drive innovation and sustain business success and quality outcomes for patients. Specialties & Interests: CMC, cell culture, cell & gene therapy, bioprocess development and engineering, optimization, validation, tech transfer, commercialization, intensification, regulatory filings
Experience
Director of Pre-pivotal Biologics Cell Culture Process Development
Jun 2024 — Present · Foster City, CA, US
Lead strategy, execution, and GMP implementation of cell culture processes for Gilead\'s early-stage biologics, driving innovation and platform evolution while shaping enterprise strategies that connect science, people, and patient impact.
Education
University of California, Davis
Bachelors of Science, Biological Systems Engineering
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.