Manufacturing Specialist I

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

Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on TIL. The company’s lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has a commercially approved product along with multiple ongoing clinical trials in various phases for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company is currently developing its commercial manufacturing capacity to support development and launch of these assets.

Essential Functions and Responsibilities

• Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
• Own and manage change controls associated with manufacturing areas and equipment.
• Participate in technology transfer, conference calls and sharing of technical information.
• Coordination of front-end document requests with supporting departments.
• Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
• Continuousl

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rs or steps.

• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

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 cleanroom setting.
• When in the lab, must be able to work in cleanroom setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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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 .

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice .