Process Development Associate II

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 Process Development Associate II Late-Stage will provide technical and analytical support for Iovances commercial Amtagvi (lifileucel) asset and other pipeline products in particular the candidate will support both clinical and commercial development projects and will have prior cell culture process development and cGLP/cGMP knowledge and experience. Priority will be given to candidates familiar with cell therapy development and relevant experience with equipment utilized in the addition candidates with demonstrated strong skills in data analysis and automation are preferred. This role is an on-site lab-based role in Philadelphia.

Specific Responsibilities

• Lead / support process development experiments involving a variety of protocols and techniques related to T cell/TIL expansion and characterization.
• Lead/support process development in automation of media and process.
• Make detailed observations and record them in a timely and relevant fashion.
• Analyze and interpret experimental results including graphing and statistical analysis.
• Organize results for team presentation and discussion.
• Lead / support write-up of protocols and associated reports.
• Provide support related to data and records management.
• Ensure training is up to date on new processes and analytical methods.
• Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
• Comply with Safety SOPs SDS sheets and laboratory procedures per company policy and OSHA regulations.
• This role is a lab-based role in Philadelphia.
• Perform all other related duties as assigned.

Education and Qualifications

• Bachelors or Masters degree (B.S./B.A./M.S.) in chemical engineering bioengineering a life science or STEM-related discipline.
• 1 years cell culture / cell therapy/biotechnology/life science industry experience.
• Proficiency in Microsoft Office Suite is required.
• Proficiency in JMP Graph Pad MiniTab and FACS DIVA software is desirable.
• Must be able to comprehend regulations and guidance documents.
• Must be analytical and able to apply critical thinking skills.
• Effective Communication Skills both written and oral.
• Must be organized able to multi-task.
• Must be a team player and contributor willing to lead or step back as the situation demands.
• Must be flexible to work independently and with a team.

Preferred Education Skill and Knowledge

• Experience with cell therapy process development is a plus.
• Prior experience with cell therapy manufacturing equipment such as NC-200 Miltenyi Prodigy flow cytometers CRF is a plus.
• Experience with JMP software is desired.
• Experience in the biomedical field is preferred.

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 move about the office and lab as needed.
• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to lift up to 15 pounds multiple times a day.
• Wear proper personal protective equipment when in a laboratory setting e. safety glasses lab coats and closed-toed shoes.

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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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.

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