Michael Jorge

WORK HISTORY

SKILLS

ABOUT MICHAEL JORGE

Pharmaceutical scientist possessing extensive knowledge and experience in analytical development with a focus on biotherapeutics. Skilled in managing contracted services (CROs, CDMOs, CMOs, and CTLs) for CMC activities. 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)• contracted services oversight managing multiple projects and third party vendors• Working within cross-functional project teams on planning, collaboration, and effective communication to meet program deliverables • Thorough understanding of the drug development process in all phase of development 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 guidelines and regional regulatory requirements• 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