Diana Serebryanik

Head of Us Quality Control @Galapagos

Staten Island, NY, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2025 — Present

Head of Us Quality Control @Galapagos

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Head of US region Quality Control for Galapagos decentralized CAR-T manufacturing model

EDUCATION

N/A

Brandeis University

Bachelor's degree, Biochemistry

N/A

Boston University

Bioinformatics

SKILLS

ValidationChange ControlManufacturingQuality ControlGmpBiotechnologyGlpAseptic TechniqueLimsAseptic Processing21 Cfr Part 11SopFdaLeadershipCapa

ABOUT DIANA SEREBRYANIK

Results-driven leader with deep experience delivering work in complex, fast-paced environments, including implementing new assays, authoring procedures, improving processes, and assay throughput. 15+ years of progressive QC leadership in clinical and commercial GMP manufacturing of cell and gene therapies including consistent delivery of on-time in-process, release and stability testing. Worked in rare disease gene therapies and autologous CAR-T (Kymriah™) manufacturing. Managed departments from 3 to 14 people, contract vendors, and special projects. SME in analytics, investigations, deviations, OOS, CAPAs, change controls, specifications, technology transfers, and phase-appropriate validations; experienced with audits, Regulatory inspections, and filings, cross-trained in quality assurance on batch records review and release and manufacturing processes. Extensive knowledge of microbiological and environmental testing, raw materials, and experience with working in clean rooms. Hard-working, strategic, efficient, and flexible; advanced problem-solving abilities, detail oriented. High customer focus, and “can do” attitude.

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Diana Serebryanik — Head of Us Quality Control at Galapagos in Staten Island, NY, US | Unifers