Overview

Iovance Biotherapeutics is a global leader in the innovation, development, and delivery of 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. Our recent launch of AMTAGVI and associated growth has led to the creation of a new position.

The Supervisor, Quality Assurance Operations (2nd Shift) will lead a team that provides oversight of the manufacture, testing, and disposition of iPBMC (irradiated peripheral blood mononuclear cells). Responsibilities will include on-floor support to manufacturing staff, Batch Record review, and review of Quality Records such as Deviations.

This is a 2nd shift position working a 4-day week: Tuesday – Friday, 5pm - 3am

Responsibilities

• Supervise the QA Operations team (2nd shift) and help drive batch disposition by performing efficient reviews of records related to the manufacture and testing of iPBMCs.
• Provide on-floor support to manufacturing staff, problem-solving or escalating issues as required.
• Support clean room readiness and release, and gowning qualification.
• Prepare and organize release documentation for Manager approval.
• Support investigations.
• Perform other duties as assigned.

Qualifications

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with a minimum of 3 years of relevant experience
• A background in cell culture, aseptic gowning and qualification, or ISO class 7 cleanroom operations is preferred.
• Good working knowledge of GMPs and cleanroom manufacturing
• Able to read, write and understand English, and be proficient in Microsoft Office (Excel, Word, Outlook).
• Excellent oral and written communication skills.
• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
• Experience with use of an electronic QMS.
• Proficient with Microsoft Word, Excel, and PowerPoint.

Physical Requirements

• Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
• Able to wear cleanroom garments and personal protective equipment (scrubs, gowning coverall, masks, gloves, goggles).
• Able to see at near and mid-range with depth perception.
• Able to stand/sit/walk for long periods of time.

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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers
• Must be able to communicate with others to exchange information

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 job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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.

lovance 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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