Process Development Associate I

Overview

The Process Development Associate I will provide process and analytical support to Tumor Infiltrating Lymphocyte (TIL) clinical and commercial development projects as part of the late-stage process development team. The successful candidate will have prior cell culture, process or method development, and cGLP/cGMP knowledge and experience. This role is a lab-based position, based in the Iovance Cell Therapy Center (iCTC) in Philadelphia, PA.

Specific Responsibilities

• Lead / support process development experiments involving a variety of protocols and techniques related to TIL expansion and characterization.
• 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
• Perform all other related duties as assigned

Education and Qualifications

• Bachelor’s degree (B.S./B.A.) in 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 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
• Team player

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, LOVO, CRF is a plus
• Experience with JMP software is desired
• Analytical skills with flow cytometry and experience with cell therapy assays including apoptosis, ELISA/ELLA is preferred

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

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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