Michael Jorge Email & Phone Number

Pharmaceutical scientist possessing in-depth knowledge and experience with a focus on analytical development of biotherapeutics. Skilled in managing contract research organizations (CRO) for preclinical and clinical studies. Experienced with investigative studies, scientific review of data, and authoring supporting documents for all phases of drug development.Specialties:• method development for biologics (ligand binding assays, immunogenicity assays, functional activity assays, biomarkers, potency assays)• CRO oversight managing multiple projects and multiple CROs• Working within cross-functional project teams, with planning, collaboration, and effective communication• Thorough understanding of the drug discovery process with a focus on pre-IND and early phases of clinical development• Knowledge of scientific standards and global regulatory requirements• Excellent experimental design, analytical, and problem-solving skills, as well as project management abilities.• Familiar with ICH M10 and regional regulatory requirements and GLP/GMP principles and regulations • Commitment to learning new technologies and flexibility in adapting to stakeholder needs• Actively involved in technology transfer, technical communication, specialty lab identification, and technical auditing

Listed skills include Assay Development, Drug Discovery, Biotechnology, Antibodies, and 46 others.

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  Uc San Diego