Senior Manager, Protein Sciences Upstream

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 Sr. Manager, Protein Sciences (Upstream) is an experienced manufacturing and processing subject matter expert responsible for managing Iovance’s GMP manufacturing operations and contracted manufacturing operations centered on protein production and characterization, with a focus on upstream process. S/He will actively collaborate with Process Development, Analytical Development,  Manufacturing, Quality Control, Quality, Supply Chain, and Regulatory functions, with a focus on ex-US manufacturing operations.

This position will report to the head of Protein Sciences, and involves planning, coordinating, and overseeing contract manufacturing and development services for Iovance products through the product life cycle. Activities requiring oversight include process development, transfer, scaleup, validation, improvements (COGS), and studies supporting technical changes/improvements. This position will also provide necessary leadership to support CMC product teams and/or lead subteams, manage technical information/data flows, manage project milestones, support audits, and assist in qualification, validation, and regulatory filing activities. Additionally, this position will be responsible for manufacturing data management for selected clinical/commercial products.  

Responsibilities

• Subject matter expert in diverse molecular biology, protein expression, and biochemistry. An understanding of analytical methods is preferred.
• Manage and/or support knowledge management (including product, process, and analytical)
• Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
• Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
• Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
• Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-