Jobs at Kashiv BioSciences LLC

Supervise QMS activities in a cGMP biologics manufacturing facility, including deviation investigations, change controls, CAPAs, document control, batch record review, audits, compliance, and continuous improvement. Lead quality data analysis, staff training, regulatory inspection support, and cross-functional resolution of manufacturing and equipment issues. The role requires onsite work in cleanroom and laboratory environments, flexible 12-hour shifts, overtime, weekends, and holidays.

Support cGMP compliance for biologics manufacturing by performing inspections, sampling, raw material release, batch and quality event documentation review, walk‑through audits, and corrective action support. Partner with cross‑functional teams to drive continuous improvement and ensure manufacturing and testing meet regulatory and company quality standards. Level of responsibility varies by MQA I–III.

Leads day-to-day operations for outsourced biologics manufacturing partners and CMO/CDMO programs. Coordinates production schedules, campaign readiness, technology transfers, validation, quality events, supply risks, partner performance, cost tracking, and cross-functional issue resolution. Supports cGMP-compliant manufacturing, inspections, investigations, and continuous improvement while providing occasional on-site campaign support. The role operates through matrix influence across Manufacturing, Quality, MSAT, Supply Chain, Regulatory, Finance, Procurement, Legal, and CMC Development.

Maintain and administer the pharmaceutical quality management system, including deviations, CAPAs, change controls, OOS investigations, complaints, risk assessments, and document control. Coordinate cross-functional investigations, monitor quality metrics, prepare trend reports, support audits and inspections, review validation documentation, and maintain inspection readiness. Provide GMP and quality-system guidance while collaborating with manufacturing, QC, validation, engineering, regulatory, and supply chain teams.

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 analytical testing and data verification for small molecule and biosimilar products in a cGMP QC lab. Run and troubleshoot protein chemistry assays (HPLC, SDS-PAGE, ELISA, capillary electrophoresis, bioassays), support release, stability, and in-process testing, author and revise SOPs and reports, investigate OOS and deviations, and collaborate cross-functionally to support regulatory interactions and continuous improvement.

Support manufacturing QMS by authoring and reviewing batch records, SOPs, change controls, deviations, CAPAs and investigations for upstream and downstream biologics. Attend production meetings, file GMP documents with QA, assist during critical campaigns, and perform up to 10% wet lab tasks. Ensure timely QMS closure and compliance with company policies.

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.

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.

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

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.

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.

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.

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.

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.

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.