Vinh Thai
Process Development | Partnering with CROs/CDMOs to Accelerate Drug Development
- Role
- Sr Associate Scientist at Apertor Pharmaceuticals
- Location
- San Mateo, CA, US
- LinkedIn followers
- 500 followers
About Vinh Thai
Process development scientist with 13+ years of experience in protein and small molecule…
Experience
Sr Associate Scientist
Apr 2024 — Present · Alameda, CA, US
Supported CMC Phase I readiness by coordinating cross-functional input from Chemistry, Biology, and Operations to aid in drafting feasibility assessments and align production timelines and budgets for drug substance and drug product.• Acted as point-of-contact between internal R&D teams and 3+ external CROs to manage delivery schedules, mitigate delays, and escalate risks.• Led method development and optimization for prep-LC workflows, enabling a 4× increase in loading capacity and a 25% reduction in run time, which drove a >400% boost in compound throughput.• Identified and qualified CRO/CMOs with mid-scale synthesis capabilities; coordinated the production and delivery of >15 high-priority compounds, and performed QC assessment using HPLC and LC/MS to verify identity and purity.• Supported internal QC workflows by evaluating analytical data, generating purity reports, and troubleshooting unexpected impurity profiles in collaboration with the analytical and synthetic chemistry teams.• Produced >500 mg of purified fermentation product across 10+ campaigns; enhanced titer 8× through fermentation and purification development.• Collaborated with CMC consultants on regulatory strategy and ICH guidelines; identified and engaged contract testing laboratories (CTLs) to perform validated assays in support of IND-enabling studies and regulatory submissions. • Implemented process control SOPs and infrastructure to improve consistency and reduce variability.• Trained and managed a junior associate to expand production capacity; led lab safety initiatives and inter-team coordination.
Education
South Colonie Central High School
High School Diploma
2004 — 2008
University of Rochester
Bachelor of Science (BS), Microbiology and Immunology
2008 — 2012
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