Gursharanjit Singh Shinh

Lead end-to-end manufacturing operations for FTO-8, driving production planning, tech transfers and GMP-ready launches; delivered 25+ tech transfers, 30+ product launches and achieved zero-observation audits across USFDA, WHO and EU while leading 130+ staff.

Led formulation development, scale-up and tech transfers for OSD and semi-solid products, interfacing between R&D and manufacturing to enable commercial launches and CMO transfers for regulated markets.

Developed and scaled oral oncology formulations for US and EU dossiers, managed exhibit/pre-exhibit batches and supported regulatory filings for ANDAs.

Formulated and scaled oral oncology products for regulated markets, managed pre-exhibit batches and supported regulatory submissions to enable ANDA progression.

Developed NDDS formulations including OSD and injectable concepts, executed scale-up and optimization batches for domestic and ROW markets improving process robustness.

Grade: 75.35%

Activities and societies: Academic project: Comparative Study on Iontophoresis and Passive Permeation using Model Drugs; publication in AAPS PharmSciTech.

Completed Master of Pharmacy in Pharmaceutical Technology with a focus on formulation and transdermal delivery research.

Completed Bachelor of Pharmacy with coursework and practical experience in formulation development and pharmaceutical systems.