Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a highly motivated Senior Quality Control Analyst at iCTC facility located in Philadelphia, PA. The quality control testing programs for critical reagents include the responsibility of reagent management, qualification and stability testing of critical reagents, and generating reports and certificates of analysis.

Essential Functions and Responsibilities

• Perform daily GMP quality control laboratory testing activities with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform cell culture, cell-based assays such as, but not limited to, flow cytometry and ELISA.
• Perform testing for trending performance and data analysis of critical reagents
• Perform critical reagent qualification and data analysis per Standard Operating Procedures
• Support thorough GMP investigations for out of specification test results and other quality events.
• Support technical problem solving for issues pertaining to GMP quality control.
• Support generation and revisions of documentation, such as SOP, protocols, and reports.
• Train new laboratory personnel
• Perform peer review of laboratory data and logbooks
• Support Trending of analytical performance
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• Support Health Authority inspections
• Provide input to functional laboratory meetings.
• Due to the nature of testing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed.
• Performs other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Knowledge of biological drug development with respect to Quality Control and Validation
• 0 -3 years of experience in the biopharmaceutical industry within a Quality Control role; experience with cell and/or gene therapy products is a plus
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Successfully interface with multi-disciplined teams in a global setting
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

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.

For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:

• Must not be color blind
• Must have 20/20 near vision in both eyes (can be corrected)

Physical Demands and Activities Required:

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must be able to work in a cleanroom lab setting with biohazards / various chemicals.
• Must meet requirements for and be able to wear a half-face respirator.
• 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 pounds

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 manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s duties 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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