Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC) Laboratory Support Analyst I who will assist the QC Laboratory Support Manager with the day-to-day upkeep of the QC investigations and supporting documentation.

The ideal candidate will have experience working in a GMP-regulated environment. The position will report to the Lab Support Manager, Quality Control.

Essential Functions and Responsibilities

• Issue, maintain, and reconcile quality control forms for environmental monitoring, microbiological, and analytical assay execution.
• Review and approve GMP quality control laboratory testing documentation at the iCTC facility with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform final result reporting and COA Generation to support product lot release with adherence to turnaround times.
• 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.
• Perform peer review of laboratory logbooks.
• 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. It is also expected that regular work weeks may change and may involve shift changes.
• Performs other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• 0-2 years of experience in the biopharmaceutical industry within a cGMP Quality Control role; experience with cell and/or gene therapy products is a plus
• Basic knowledge of biological drug development with respect to Quality Control
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges

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 wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 12-hr day which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 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 deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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.

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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