Giuliana Medrano
Sr Director, Quality Control - Cgmp, Cell Therapies @Garuda Therapeutics
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WORK HISTORY
Sr Director, Quality Control - Cgmp, Cell Therapies @Garuda Therapeutics
Cambridge, MA, US
Built in-house capabilities for GMP testing of iPSCl-derived clinical-grade cellular products. • Established the Quality Control Lab from the Get-Go in time record, including internal / external testing, equipment GMP readiness, monitoring systems, etc. • Authorship of Specifications, COA, Stability Programs, Sampling Plan, Risk Assessment, Quality documentation. • Write/review/approve more than 100 technical documents (e.g, SOPs, protocols, reports, spec, etc.) that support IND/CTA submissions • Support strategic planning by timely communication of QC deliverables, constraints, risks, and options, and collaborating with key stakeholders (CMC, QA, AD, Regulatory, etc). • Support and review EMPQ Qualifications, Gowning Qualification, Risk Assessments. • Implemented eight (8) phase-appropriate method qualification internally in time record. • Perform technology transfer internally and to contract testing labs and corresponding risk/gap assessment. • Write/review/approve deviations, investigations, CAPAs, OOS, OOT both within the Company and with CMOs. • Establish, administer, and maintain policies, standard operating procedures (SOPs), work instructions, and forms relating to the QC function and the QMS. • Lead, supervise, and train QC and associated staff in complex cell culture, human blood, and blood products using aseptic techniques and complex methods. • Managed extensive testing panels (30+ testing per panel) and working with CTL, CMO, CLO and contractors. Establish NDA, SOW, Quality agreements. • Perform external on-site audits for the testing vendors. • Developed QC reference controls and cell banks. • QC Equipment/Systems readiness, IQ/OQ/PQ, calibration, established and implemented schedules, trainings logbooks and documentation. • Continuous improvement projects to reduce lab errors, increase team working efficiency and improve compliance. • Outstanding time management skills, consistently meet aggressive timelines, excellent organizational skills.
EDUCATION
Universidad Nacional Federico Villarreal
MS, Microbiology
Universidad Nacional Mayor de San Marcos
DVM, Veterinary Medicine
Universidad Peruana Cayetano Heredia
PhD, Biochemistry and Molecular Biology, 2006
Universidad Nacional Mayor de San Marcos
BS Veterinary Medicine, San Marcos University, Lima, Peru, 2000
ABOUT GIULIANA MEDRANO
Experienced and highly motivated Quality Control professional with 10+ years of relevant industry experience. Manage lifecycle documentation; lead tech-transfer of analytical methods; conducting qualification of phase-appropriate methods; management of quality systems; overseeing external testing vendors (CROs, CTLs, CMOs); support IND and CMC activities; conduct audit and EU GMP compliance readiness activities in cell / gene therapies in clinical trials. Expertise in support Quality Control testing panel (30+ different testing per panel, per product) and testing specific for CRISPR technology. Authorship of Specifications, COA, Stability Programs, Sampling Plan, Risk Assessment, and other Quality documentation. Expert in establishing new QC laboratories, systems, processes for new QC operations. QC representative in leadership decisions with senior management to achieve strategic plans and objectives in the department. Expertise in managing quality events and activities: OOS, OOT, Deviations, Lab Investigation, Change control, CAPA, etc. Oversees EMPQ programs, gowning qualifications and other QC microbiology related to Manufacturing operations. Managed critical raw materials testing and life cycle. More than 20 years of experience in Analytical Development field including planning, designing, and implementing projects that encompass molecular biology, cell biology, virology, recombinant protein, immunology, microbiology, following ICH guidelines. This extensive Analytical Development know-how integrated with CMC/QC expertise provides unique ability to consistently achieve successful results as a QC leader in all stages of the product from raw materials to batch release.
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