Jobs at Kashiv BioSciences LLC

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

The LIMS Implementation Coordinator aids in implementing Caliber LIMS, coordinating activities across multiple teams, and managing documentation in a GxP environment.

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

Support GMP manufacturing by authoring and managing controlled documentation (SOPs, batch records), driving deviation/CAPA/change control workflows, coordinating cross-functional closure of quality records, maintaining training curricula, supporting cleanroom operations, and tracking manufacturing/quality KPIs to ensure compliant, on-time delivery.

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.