Jobs at Orca Biotech

Manage full-cycle accounts payable, prepaid expense amortization and reconciliations, expense report review, Sunshine Act reporting support, monthly/quarterly/year-end close entries and schedules, sales/use tax and 1099 filing, and audit support.

Field-based account manager responsible for building and maintaining relationships with Authorized Treatment Centers, ensuring site readiness and operational logistics (COI/COC), supporting clinical and commercial engagement, driving therapy utilization, gathering market insights, and representing the company at conferences. Role requires strategic planning and tactical execution to enable delivery of cell therapy treatments.

Orca Bio invites passionate candidates to join their talent community, focusing on transformative next-generation cell therapies and innovative contributions.

The Lead Clinical Data Manager oversees all clinical trial data management processes, ensuring compliance, accuracy, and timely database management from study start to close, and collaborates with teams to resolve data issues while maintaining adherence to regulatory standards.

Support development and tech transfer of antibody and antibody-conjugate manufacturing in a GMP environment. Perform development and engineering runs, troubleshoot processes, manage GMP clean room tasks, run assays, stability and formulation studies, maintain detailed records, and collaborate with manufacturing, quality, facilities, and supply chain teams to advance clinical pipeline.

Manage quality systems (deviations, change control, CAPA, document control), review batch records and make batch disposition decisions, support audits, train staff, and drive continuous improvement to ensure GMP and regulatory compliance in a cell therapy manufacturing environment.

Manage QA systems for GMP cell therapy manufacturing including deviations, change control, CAPA, document control, and batch disposition. Review batch records, support audits, train staff, ensure regulatory compliance, and drive continuous improvement to maintain product quality and data integrity.

Oversee day-to-day operation of the MasterControl training system: manage user access, curricula, onboarding/offboarding, maintain audit-ready training records, troubleshoot system issues, deliver onboarding training, and provide reporting to ensure GMP training compliance.

Lead commercial legal function supporting the first U.S. product launch. Provide legal advice to Commercial, Medical Affairs, Market Access and Patient Support on FDA promotional rules, pricing, contracting, compliance (AKS, FCA), review promotional/medical materials, oversee outside counsel, develop policies, training, and support compliance program evolution.

The Senior Manager / Associate Director, Cost Accounting leads cost accounting for manufacturing, overseeing product costing, inventory valuation, and financial compliance while supporting the transition from clinical to commercial stages.

Lead build-out of enterprise data infrastructure and KPIs, manage data collection, validation, pipelines, dashboards and reporting. Conduct primary market research and competitive intelligence, synthesize insights for leadership, support forecasting and launch readiness, and partner cross-functionally while managing vendors and analytics workflows.

Support execution and documentation of process improvements, change controls, CAPA, and SOP development in a GMP-regulated cell therapy manufacturing facility. Coordinate data collection, assist root cause investigations, track project milestones, and facilitate cross-functional meetings and training to ensure compliant implementation of production changes.

Support the CEO and President by coordinating executive priorities, preparing board and executive materials, driving cross-functional strategic initiatives, improving operating rhythms, and tracking progress on company priorities. Act as a central coordinator for communication, decision-support, and follow-through across leadership teams to scale organizational effectiveness during the companys transition to commercial-stage.

Coordinate vein-to-vein logistics: schedule and adjust runs, assign porters and third-party couriers, prepare batch paperwork, track calendars and shipments, reconcile expenses, and serve as cross-trained backup managing live runs, incident response, and contingency decisions.

The Orca-T Account Manager will liaise between Orca Bio and Authorized Treatment Centers, manage relationships, ensure operational readiness, and drive therapy utilization while supporting clinical engagement.

The HR Manager partners with site leaders to enhance talent management, coaching, employee relations, and HR compliance, ensuring effective operational practices across manufacturing.