Senior Process Technical Services Specialist

About the role

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. Essential Functions and 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. Quality Systems - Change Control (tech transfer, process improvement, emergency etc.), Deviations / LIRs (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution) Study or investigational protocols and corresponding reports Process Characterization, Validation, Qualification protocols and reports Product Impact and Risk Assessments, Failure Modes Risk Analysis SOPs, COPs, PTS MBRs Senior Specialists will be responsible for managing PTS department Quality System metrics and managing complex investigations (CAPA, Deviation, etc.) related to the manufacturing process. Investigation activities may include execution of studies, GEMBA, Kaizen, Risk Analysis, etc. through to completion. Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Will assist manufacturing and quality when authoring Master Batch Records and implementing process improvements. Analyze and interpret manufacturing process data and ensure process trends are addressed appropriately. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the manufacturing operations environment. Execute hands on experiments in the iMAPs lab (as applicable). Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge Bachelor's degree in a relevant discipline or equivalent industry experience. Requires a minimum of 8 years of related experience with a Bachelor's degree; or 6 years with a Master's degree; or a PhD with 3 years of experience; or equivalen

Additional Information

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.

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