Jobs at SOKOL GxP Services

Coordinate supply, demand, and logistics between internal teams and CMOs to support GMP-regulated production schedules. Execute and track orders in SAP/ERP, manage shortages, rework, and quality events, maintain order reporting for GMP materials and finished drug products, support forecasting, inventory planning, backorder management, and escalate supply risks to management.

Hands-on role to design, program, qualify, and optimize automated QC assay workflows for cell therapy products using liquid handlers. Responsibilities include translating manual assays to automation, troubleshooting scripts/instruments, supporting method qualification/validation, authoring GMP documentation, and collaborating with QC, analytical development, and automation teams to enable technical transfer and continuous improvement.

Support procurement and P2P operations for biologics development in a GMP-regulated environment. Create and track purchase requisitions and orders, manage vendor sourcing and quotations, monitor deliveries and installations, maintain audit-ready procurement documentation, reconcile invoices, coordinate cross-functional stakeholders, escalate issues, and support SOP and compliance adherence.

Provide administrative and project support to senior leaders across multi-site biologics development teams. Manage complex calendars, meetings, travel, expense reports, onboarding/offboarding, SharePoint and OneNote documentation, town halls, communications, and Microsoft-based survey and documentation tools while maintaining confidentiality and cross-site coordination.

Provide on-the-floor QA support for biopharmaceutical manufacturing: perform real-time batch record reviews, approve shop-floor documentation, identify and escalate quality issues, support deviations/change control/CAPA, apply Quality Risk Management, and develop/revise GMP procedures while partnering with manufacturing and cross-functional teams.

Plan and manage supply for drug substances, products, and finished goods across internal and external sites. Maintain inventory accuracy, manage POs, monitor demand changes, identify supply risks, support stock reviews/forecasting, participate in supply chain meetings, support new product introductions and regulatory-related inventory investigations, and produce reporting using ERP and BI tools.

Perform microbiology laboratory testing (bioburden, microbial counts, growth-promotion) using aseptic technique; maintain lab operations and equipment; document results and write test and final reports; support technology transfer, microbial-characteristics testing, and development of electronic checklists for sterility and microbial-control activities.

Author and co-author CMC regulatory documentation (Module 2.3 and Module 3) for a late-stage cell therapy program. Coordinate source documents, manage submission timelines, review and adjudicate comments, verify data, ensure dossier consistency, and collaborate cross-functionally with development, quality, regulatory, project management, document management, and external vendors.

Support and lead deviation investigations and CAPA activities in a GxP biopharmaceutical setting. Perform root cause analysis, author technical investigation reports, implement CAPAs, conduct GEMBA walks, support change control, audit readiness, and continuous improvement with cross-functional teams.

Support GMP cell therapy manufacturing by executing aseptic experiments, operating automated equipment, analyzing data, drafting technical reports, coordinating with analytics, and supporting investigations, comparability and validation studies. Occasional early/late or weekend work for cell culture maintenance.

Coordinate procurement for capital equipment, laboratory supplies, and vendor services. Create and track requisitions and purchase orders, collect supplier quotes, monitor deliveries and installations, liaise with internal teams and vendors, manage invoices and reconciliations, and maintain procurement documentation to ensure compliance and audit readiness.