About Me
Jimmy Goncalves is a professional operating at the interface of scientific development and business strategy within a contract research organization (CRO) environment. His work focuses on supporting CMC and clinical-stage programs through assay development, regulatory alignment, and client engagement.
Professional Focus
- Coordinates development and validation of bioanalytical and analytical assays, including qPCR, ddPCR, LC-MS/MS, NGS, and CBA/potency assays for cell and gene therapy therapeutics and related modalities
- Supports clinical and IND-enabling programs with emphasis on regulatory compliance, including GLP, GMP, and 21 CFR Part 11 frameworks
- Engages in technical scoping, proposal development, and due diligence responses for clients across biotechnology, vaccine, and microbial testing sectors
Role in CRO Environment
- Affiliated with Avance Biosciences, providing integrated bioanalytical and genomics services
- Serves as a scientific and commercial liaison, translating complex assay requirements into structured study designs and executable proposals
- Supports end-to-end project lifecycle activities, from early feasibility discussions through validated assay deployment and reporting
Technical Capabilities
- Molecular assay platforms: qPCR, ddPCR, TaqMan-based detection systems
- Genomics: Whole Genome Sequencing (short- and long-read), single-cell sequencing, amplicon sequencing, GUIDE-seq, rhAmpSeq
- Regulatory documentation: Validation protocols and technical reports
Working Approach
- Emphasizes structured, decision-oriented communication aligned with scientific and regulatory standards
- Prioritizes clarity in early-stage discussions while maintaining technical rigor
- Focuses on actionable outcomes, including defined scope, timelines, and deliverables
- Applies a systems-oriented approach to both scientific workflows and business process optimization
This profile reflects a combined scientific and operational role, with emphasis on translating complex analytical requirements into compliant, executable solutions for clinical and preclinical programs.