Celldex Therapeutics
The role oversees and coordinates validation projects to ensure new and existing computer systems meet regulatory compliance such as 21 CFR Part 11, EU GMP, and GLP throughout their lifecycle. It serves as the primary subject matter expert for computer system validation and quality risk management, developing SOPs, training, and managing change control activities across cross‑functional teams.
Celldex Therapeutics is a clinical-stage biopharmaceutical company pioneering immunology-based therapies to treat severe inflammatory, allergic, and autoimmune diseases. Their lead program, barzolvolimab, is a humanized monoclonal antibody inhibitor of KIT designed to target mast cells as a core driver of disease. The company leverages deep expertise in antibody-based immunotherapies and proprietary technologies to discover and develop innovative treatments.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Celldex Therapeutics.
12% below the average for this role
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