Jobs at Iovance Biotherapeutics, Inc.

Manages GMP and contracted manufacturing operations for protein-based products, specializing in downstream processing, formulation, fill-finish, and lyophilization. Oversees process development, technology transfer, scale-up, validation, COGS improvements, manufacturing readiness, quality investigations, regulatory CMC support, and data management. Collaborates globally with CMOs, Quality, Regulatory, Supply Chain, and technical teams while supporting audits, product lifecycle activities, and staff development.

Own the architecture and hands-on implementation of an enterprise Windows endpoint platform using Intune, Autopilot, Entra ID, PowerShell, and Microsoft 365. Responsibilities include device provisioning, configuration and compliance policies, application packaging, remediation, performance baselines, driver management, documentation, and support-team training. The role also builds SharePoint Online solutions, Power Automate workflows, and Microsoft Forms integrations for business processes, while partnering with security, quality, and business stakeholders in a regulated biotech environment.

Provides fully onsite Tier 1 and Tier 2 IT support at a manufacturing facility, troubleshooting hardware, Microsoft 365, mobile devices, printers, conference systems, networks, and Intune-managed devices. Responsibilities include ticket management, imaging, patching, asset documentation, onboarding and offboarding, executive and laboratory support, event assistance, reporting, vendor coordination, and user training. Requires strong customer service, communication, hardware troubleshooting, Microsoft 365 proficiency, and familiarity with ITIL and GxP practices.

Leads complex, cross-functional project portfolios for manufacturing sites, overseeing planning, execution, budgets, timelines, risks, interdependencies, and stakeholder alignment. Establishes project management standards, dashboards, and metrics; coaches project managers and teams; drives continuous improvement and change management; and reports progress to senior leadership. The role operates in a matrixed organization and may involve travel, with work performed in office and manufacturing lab environments.

Develops and maintains manufacturing and quality control master schedules for cell therapy operations. Performs capacity planning, evaluates constraints involving staffing, equipment, materials, and testing, and leads monthly S&OP capacity planning. Collaborates with manufacturing, quality, logistics, sales, purchasing, suppliers, and contract manufacturers. Supports facility projects, tech transfers, validation, maintenance, planning-system improvements, and schedule adherence while optimizing production capacity and patient opportunities.

Contract Statistical Programmer to develop, validate, and maintain SAS/R programs producing SDTM/ADaM datasets and TLFs per CDISC and regulatory standards. Support analyses for safety reports, submissions, and ad hoc requests; perform QC, documentation, automation, and collaborate with biostatistics and data management in a GxP-compliant environment.

Serve as lead statistician for cell therapy oncology studies: design studies, perform statistical analyses, author SAPs and reports, oversee CRO statisticians/programmers, support regulatory submissions, and drive biostatistics best practices and process improvements.

Support cell therapy manufacturing as an MSAT subject-matter expert: analyze manufacturing data, lead tech transfers, author protocols/reports, oversee GMP operations, perform lab experiments, and support investigations and process improvements across internal and external manufacturing sites.

Lead development and execution of investor relations and corporate communications materials and programs. Support investor and media engagement, translate company milestones into clear messaging, manage events and vendors, partner cross-functionally to ensure accurate, compliant communications, and improve processes to scale IR and communications functions.

Provide legal support for contracting: review, negotiate, and manage third-party agreements; develop and maintain contract templates; advise on contract management system and policies; train internal clients; research legal issues; prepare contract summaries for executives; ensure compliance with company legal processes while collaborating with in-house legal team.

The Lifecycle Leader is responsible for shaping the strategic vision and lifecycle plan for tumor infiltrating lymphocyte therapy, ensuring optimal program execution across multiple teams and stakeholders, and guiding the decision-making process for clinical and commercial goals.

Manage QC documentation and data in support of lot lifecycle: issue testing forms, maintain LIMS entries, generate Certificates of Analysis/Testing, track record status, and assist with high-volume QC documentation projects and record completion.