Matt Castellino
Senior Manager, Quality Assurance @Kite Pharma
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WORK HISTORY
Senior Manager, Quality Assurance @Kite Pharma
Santa Monica, CA, US
Manage and develop Quality Assurance staff in support of the Global QC Organization as part of cell-therapy manufacturing. Review batch-related documentation and ensure issue resolution to release product. Assist in the raw material disposition process including Material Review Board meetings. Manage regulatory inspections, internal and external audits while providing direction at the site and corporate level. Develop and implement Quality on the floor processes and implement process control measures for Centre of Excellence labs. Ensure all Change Controls, Deviations and CAPAs within area of responsibility are initiated, evaluated and implemented.
EDUCATION
California Polytechnic State University-San Luis Obispo
Bachelor of Science (B.S.), Microbiology - Applied Microbiology and Biotechnology
SKILLS
ABOUT MATT CASTELLINO
Dynamic and results-driven Quality professional with extensive GxP experience in directing all aspects of business operations in various manufacturing settings.As an Operations leader, I have a stellar track record of defining and executing robust manufacturing and quality assurance strategies to meet organizational objectives and milestones. My expertise lies in leveraging industry best practices and technologies to ensure the highest quality of all products and services. Additionally, I have extensive experience in creating processes for start-ups and technology transfers under strict timelines and budgetary constraints. I serve as a subject matter expert in pharmaceutical aseptic manufacturing operations, quality and regulatory compliance. I possess strong business acumen and the ability to monitor the health of business objectives and quality systems. My well-rounded skill set includes excellent problem-solving, customer service, quality control, analytical, and decision-making abilities, with a keen attention to detail. My excellent communication skills have enabled me to work well with cross-functional teams.Technical Expertise: Quality Assurance | Process Improvement | Clinical Manufacturing | Team Building & Leadership | SOP Development, cGMP, cGLP, GDP | Regulatory Compliance | Cell Therapy, Recombinant & Plasma Proteins | Aseptic Filling & Finishing | Cell Culture/Purification | Strategic Planning & Execution | Risk Analysis & Mitigation | Lean Manufacturing & Six SigmaKey Accomplishments:• Led and monitored all startup processes, as well as acquired licensing of new formulation and filling plant.• Met all supply chain demands by leading technology transfer and drug product scale-up process optimization.• Developed and administered all quality assurance processes for submission of investigational new medicines and qualification of clinical manufacturing facilities.• Designed and created efficient quality systems to asses and identify defects in sample products
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