Process Development Associate [Contract to hire]

Overview

The Process Development Associate I will support process development projects and technology transfer activities related to genetically and non-genetically engineered Tumor Infiltrating Lymphocyte (TIL) clinical trials. A successful candidate will have experience with aseptic cell culture techniques and cell-based immunological assays. Prior knowledge of cGMP practices is beneficial in this role.

Essential Functions and Responsibilities

• Primarily focus on process development aspects of clinical-scale cell processing: mammalian cell culture, drug product formulation, and cryopreservation of cell products.  Development of new processes or refinement of existing ones to optimize the manufacturing process. Perform characterization testing on cell products.


• 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.


• Remain current with 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.

Required Education, Skills, and Knowledge

• Bachelor’s with 2+ yrs/Master’s with 0+ yrs degree in a life science or STEM-related discipline


• 2+ years of cell culture/ cell therapy biotechnology life science industry experience


• Proficiency in Microsoft Office Suite


• Must be able to comprehend regulations and guidance documents


• Must be analytical and able to apply critical thinking


• Effective written and oral communication skills


• Must be organized, able to multi-task


• Work well in team environment

Preferred Education, Skills, and Knowledge

• Proficiency in Graph Pad, MiniTab


• Proficiency with FACS DIVA software


• Previous cell therapy experience; experience with TIL or CAR-T is an added plus


• Previous Immunological Assay experience (flow cytometry, ELISA) is an added plus

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 to and from the office to the lab located on separate floors and 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 move and lift containers of fluid weighing 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.

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 [email protected].

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. 

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