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

The ASaT Specialist is accountable for the technical development of quality control methods and processes, method and instrument validations, and technical transfers related to Analytical and/or Microbiological quality control testing of products, raw materials, and packaging components at the site. This role is also responsible for operating and maintaining quality control instrumentation in compliance with cGMP/FDA regulations, Iovance standard operating procedures, and policies. Given the nature of the process, this role also necessitates expertise in quality control techniques, analytical instrumentation, sterility principles, and an understanding of radiation safety standards.

Essential Functions and Responsibilities:

• Executes testing for method and instrument implementation and qualification/validation protocols.
• Supports Phase II LIR OOS/OOT investigational testing.
• Responsible for the timely completion of required, including SOPs, aseptic techniques, gowning, testing, and EHS.
• Prepares applicable documents, forms, and records, such as method or instrument qualification/validation records, and follows Good Documentation Practices.
• Supports internal and external Audits and Inspections, if needed.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Required Education, Skills, and Knowledge:

• A minimum of a bachelor’s degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field and 1-3 years of experience is required.
• Solid understanding and functional knowledge with hands-on experience with Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays.
• Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)
• Successfully interface with multi-disciplined teams.
• Extremely detail-oriented with strong technical skills.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability.
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

Preferred Education, Skills, and Knowledge:

• Master’s degree with four years of experience.
• Experience with cell therapy products is a plus.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must be able to work in a lab setting with biohazards / various chemicals.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing up to 45
• 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 when not in a lab setting.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
• 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 laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste.

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