Senior Manager, Protein Sciences Downstream

About   Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics , Inc.  is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The  Iovance TIL platform  spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit  www.iovance.com .

Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on  www.iovance.com .

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, 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 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 focus on aseptic operations and commercial manufacturing, is preferred.

Must possess a thorough understanding of biotherapeutics manufacturing.