Teams at Kashiv BioSciences LLC

Perform cGMP analytical testing and data verification for clinical and commercial biosimilar products. Troubleshoot protein-chemistry assays (HPLC, SDS-PAGE, CE, ELISA, cell-based bioassays), support release, stability, and in-process testing, lead OOS investigations and CAPAs, author and review QA/QC documentation, collaborate cross-functionally, train analysts, and support audits and regulatory interactions.

The Manufacturing QMS Specialist will support documentation for manufacturing processes, including the review of batch records and managing deviations and change controls.

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