Teams at Kashiv BioSciences LLC

Perform downstream purification processes at multiple scales in a cGMP environment, including column packing, process troubleshooting, and data analysis. Provide technical direction for purification development and execution, collect and evaluate operating data for process adjustments, and prepare/review quality management documents (deviations, change control, investigations).

Execute and review HPLC/UPLC assays, impurity testing and bioassays for release and stability in a GMP QC lab. Write experiment summaries, investigations, technical reports, SOPs, test methods, and validation protocols; review/approve CCRs and provide analytical support for formulation development.

The Engineering Manager oversees site engineering, facilities, maintenance services, and ensures compliance with quality and regulatory requirements while managing staff and improving processes.