Quality Assurance Intern

Описание вакансии

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:

Iovance Biotherapeutics is a global leader in innovation, development, and delivery of 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.

Our 2024 FDA approval of AMTAGVI® is the first and only FDA-approved one-time T cell therapy treatment for individuals with previously treated melanoma that has spread or cannot be removed by surgery.

The Quality Assurance (QA) department ensures that day-to-day QA Operations activities are performed in accordance with current Good Manufacturing Practice (cGMPs), the Code of Federal Regulations (CFR), International Council for Harmonisation (ICH) guidelines and company policies and procedures. We work onsite alongside manufacturing and quality control personnel, helping to maintain the highest standard of work for Iovance’s in-house manufacturing activities at 700 Spring Garden St, Philadelphia, PA., which is co-located at the American Red Cross Penn Jersey Region.

The quality assurance project lead intern will possess a passion for learning. Successful applicants will have an interest in Good Manufacturing Practices (GMP) manufacture of cellular materials. Candidate should have excellent communication skills and a proven history of innovation and teamwork. They should have the capacity to recognize problems and propose solutions.

At the completion of the program, the candidate will have an understanding of good documentation practices (GDP), good manufacturing practices (GMP) and quality assurance (QA) within a biotechnology manufacturing site.

Responsibilities:

• Shadow QA team members in their work.
• Effectively interface with quality assurance and manufacturing departments to learn about the process observation function.
• Work with SME mentor to develop overview of process observation task.
• Draft training script for process observation task using existing template.
• Integrate input from subject matter expert and trainers to create robust training script.
• Reference current job aids in creation of training materials.
• Deliver a department presentation at the end of the program.

Education:

• Candidate must currently be enrolled in an undergraduate degree program at an accredited university.

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 move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• 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 job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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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.

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