Jobs 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.

The Manager of CMO Operations oversees outsourced production and compliance with GMP standards across contract manufacturing organizations, ensuring reliable supply and high-quality performance. Responsibilities include managing partnerships, overseeing manufacturing metrics, and leading initiatives for operational excellence.

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 Senior Scientist will develop and validate analytical methods, conduct tests, write protocols, and provide training, ensuring compliance with regulations while managing lab operations and improving methods.

The QC Analyst III conducts analytical testing, data verification, method validation, and collaborates across departments in a cGMP laboratory setting.

On-site IT Systems Support Specialist responsible for Tier 1 support of desktops, laptops, servers and networks, AD/Azure AD account management, Office 365 administration, ticketing (Zendesk), remote support, endpoint security, and supporting GMP/GxP-validated lab systems and documentation. Supports audits, system validation, and occasional travel between sites.

This role involves developing LC-MS methods for protein characterization, supporting biosimilar development, and ensuring compliance with regulatory standards while collaborating with teams and writing technical documentation.

The QC Analyst II conducts analytical testing and data verification for clinical and commercial products, ensuring compliance with cGMP regulations and collaborating across departments to resolve issues and improve processes.

Perform hands-on upstream biomanufacturing activities in a cGMP environment including bioreactor setup/operation (50–2000L), media/buffer preparation, filtration, aseptic techniques, in-process sampling, documentation, inventory management, and support for audits and investigations. Work 12-hour shifts with physical handling of materials and adherence to safety and quality standards.

Develop, optimize, qualify, and validate protein analytical methods (HPLC/UPLC, capillary systems, plate assays) under GLP/GMP. Document experiments, write technical reports and SOPs, and support lab operations in a controlled cleanroom environment, ensuring compliance and team collaboration.

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.

Perform and coordinate microbiological testing and product release in a cGMP biologics/biosimilars manufacturing lab. Duties include organism identification, reading/interpreting cultures and sterility tests, reviewing batch records and environmental monitoring, supporting validation/technology transfer/troubleshooting, writing procedures, and preparing reports to ensure aseptic quality and regulatory compliance.

Support and manage QA activities for biologics/biosimilars manufacturing: review and assemble batch and quality documentation, oversee document control, perform sampling and release of materials, support investigations (deviations, CAPAs, change controls), assist validation/qualification, conduct GMP walk-throughs, and collaborate cross-functionally to ensure compliance with cGMP and company procedures.

Hands-on biomanufacturing role executing downstream purification of recombinant proteins (50–2000L) in cGMP cleanrooms. Operate and troubleshoot chromatography, TFF, and controllers; perform calculations, solution preparation, material staging, inventory, and real-time documentation. Support investigations, audits, and cross-functional coordination. Follow safety, aseptic and data integrity standards; work 12-hour shifts including nights/weekends and lift/transport heavy materials.

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.