Manager, Manufacturing Operations at Iovance Biotherapeutics in Philadelphia, PA

Job description

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 In this postion, one provides guidance and oversite to the process and production as well as timely document review, ensuring material is made in a safe and compliant manner and meeting company targets. This individual is directly responsible for the teams whose goals are to produce products on the manufacturing floor. The Manufacturing Manager is also responsible for the development of staff, to accommodate Iovance's needs as a growing organization. Rotation Schedule: Week 1: Shift A: Sunday to Wednesday from 1700 to 0430 Week 2 Shift A: Sunday to Tuesday from 1700 to 0530 Essential Functions and Responsibilities Oversees the Manufacturing Operations team to support clinical and commercial production. Develop schedules for manufacturing that meet monthly and quarterly targets. Ensure resources are adequate to complete operations and fully optimized from an operational excellence perspective. Lead critical level investigations as related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as Partner with Quality to address these issues effectively and compliantly. Identify, lead, and implement continuous improvement opportunities for process and production related items. Expert level in visual management, KPIs, huddle boards etc. Continuously seek and support new approaches, practices, and processes to improve the efficiency and effectivity of the operation. Ensure batch-related documentation (batch records and SOPs) is closed in a timely manner to support batch Since it is a just-in-time manufacturing process, careful coordination and communication will be required between Operations, Quality Release and Supply Chain team. Maintain robust training program to ensure timely, efficient, and effective training of individuals. A highly effective "First time right" program is required for autologous cell Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per Develop and provide monthly manufacturing metrics and "Health of the Operations" Lead personnel actions to include recruiting, onboarding, performance management, training, promotions, transfers, etc. Supervision and development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence. Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management. Author and revise do