Khushbu Patel

WORK HISTORY

EDUCATION

ABOUT KHUSHBU PATEL

Analytical Development & Quality Control Director with broad end-to-end experience from DNA-encoded library (DEL) drug discovery through late-stage development across small molecules, oligonucleotides, macrocyclic peptides, and proteins. Demonstrated leadership in analytical strategy for oral solid dosage forms, inhalation products, sterile injectables, medical devices and combination products.Strong track record in building high-performing analytical teams, driving long-term CMC strategy, and advancing complex programs from early research to clinical and commercial phases. Recognized SME in Separation Science (HPLC/UPLC), Mass Spectrometry (MS), and Dissolution, with deep expertise in analytical method development, validation, transfer, scale-up, and troubleshooting.Lead for global analytical and bioanalytical activities with effective oversight of CRO/CDMO partnerships, ensuring scientific rigor, operational excellence, and regulatory compliance. Skilled in budget planning, resource allocation, and optimizing analytical workflows across multiple modalities and development stages.Bring strong knowledge of cGMP, regulatory expectations, and CMC documentation for ANDA, IND, IMPD, QOS, IDE, PMA, and NDA submissions. Known for decisive, results-driven leadership, cross-functional collaboration, risk assessment, and fostering a culture of quality and continuous improvement—accelerating development while maintaining the highest scientific standards.