Sr. Manager, Protein Sciences (Downstream) - GMP Manufacturing Operations

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 (Downstream) 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 downstream process, including drug product formulation, fill, and lyophilization. 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. Oversight includes process development, transfer, scale-up, 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 protein purification, drug product formulation, fill, and lyophilization.
• 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-US.
• Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations, and CAPAs as required. Support and participate in site audits, as required.
• Manage and/or support hiring and development of staff, as required.
• Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
• Utilize strong operational excellence/lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

Required Experience

• A minimum of 9 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 4 years experience in a relevant Life Science discipline or equivalent in work experience.
• In-depth understanding of protein purification, characterization, drug product formulation, fill, and lyophilization. Good understanding of protein expression, cell culture processing, and QC methods is a plus.
• Strong prior operational experience preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality, and Regulatory functions, with commensurate experience supporting internationally licensed products.
• Direct experience managing contract development/manufacturing organizations (CDMOs), with a focus on aseptic operations and commercial manufacturing, is preferred.
• Must possess a thorough understanding of biotherapeutics manufacturing.
• Demonstrated business and commercial focus with awareness of customer/patient-centric issues.
• Experience working in a global business environment across multiple time zones.
• Self-starter, possessing strong verbal and written communication skills.
• Ability/willingness to travel globally for extended periods, based on business needs.

Physical Demands and Activities Required:

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to work on a tablet or computer for 80% of a typical working day.
• Must be able to move and lift 15 pounds.
• Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress.
• Ability to handle multiple priorities simultaneously.
• Ability to meet deadlines.

Work Environment:

• This position will work in both an office and a manufacturing setting.
• Potential exposure to noise, equipment hazards, and strong odors.