Manager, Quality Assurance Operations

The posting, as Iovance Biotherapeutics wrote it

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 Manager, Quality Assurance (QA), IOVA-A QA Ops is responsible for supporting day-to-day GMP QA Operations activities that support manufacturing, testing and release of iPBMCs in a GMP compliant manner. The individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The Manager provides overall Quality Assurance support including, but not limited to, review

and approval of qualification protocols/reports, validation protocols/report, batch record review and release of manufactured lots. The successful candidate will work on-site and will manage the internal QA Operations team. The Manager is an effective communicator and is comfortable working in a complex and fast-paced environment.

Essential Functions and Responsibilities

Quality Assurance Operational Support

• Ensure that day -to-day activities for QA Operations and lot disposition are efficient, coordinated, and executed as planned.
• Ensure efficient operations, and compliance with quality standards, cGMPs, safety regulations, and requirements as documented.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
• Contribute to strategic and tactical decisions based on sound Quality principles and available data. Provide quality direction to, and gain alignment across, functions who are problem solving.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operatio

[…]

• Must be able to perform cleanroom gowning and pass gowning
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

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; and ability to meet deadlines.

Work Environment

This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

#li-onsite

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com .

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