Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors.

We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Senior Process Technical Services Specialist is a senior-level manufacturing operations subject matter expert responsible for technical leadership across cell therapy manufacturing processes. This role contributes deep expertise in aseptic technique, laboratory execution, and process science, and is responsible for leading technology transfer activities, supporting complex investigations, driving process improvements, and providing ongoing technical support for manufacturing operations.

The Senior PTS Specialist also authors and supports protocols and reports, mentors junior staff, and partners cross-functionally to ensure robust process performance across small-scale and full-scale manufacturing.

Responsibilities

Subject matter expert in aseptic technique, laboratory execution, and cell therapy manufacturing processes, representing PTS in cross-functional meetings and technical discussions. Lead technology transfer activities to and from internal and external manufacturing facilities, including process implementation, process translation, training support, and cross-site technical support. Own and project manage major change controls, including those associated with regulatory actions, and lead process hyper care to determine whether additional CAPAs or change controls are required.

Lead investigation teams and support the initiation and execution of complex manufacturing and process improvement investigations, including completion of minor and major deviations, creation of risk assessments, and execution of related study activities as needed. Author, review, approve, and support technical documentation as delegated, including protocols, reports, risk assessments, manufacturing support documents, and quality system records. Drive continuous improvement by leading GEMBA walks, identifying process improvement opportunities, and spearheading implementation of approved improvements.

Analyze and interpret process data using statistical tools such as Minitab and JMP to support troubleshooting, process monitoring, trend evaluation, and data-driven decision-making. Train and mentor staff as a process SME, support junior staff with protocol and report development, and provide guidance on most or all process-related topics. Provide audit and inspection support as a process SME and serve as a functional reviewer and approver for delegated documents.

Support manufacturing activities across small-scale and full-scale operations and perform other duties as required to meet departmental and business needs. ) related to the manufacturing process. Investigation activities may include execution of studies, GEMBA, Kaizen, Risk Analysis, etc.

through to completion.