Overview

The Quality Control Analyst I supports quality control testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control testing programs include but are not limited to, in-process, final drug product, and stability testing with a focus on cell therapy products. This role requires hands-on laboratory experience in at least one of the following: cell culture / maintenance and cell count determination (NC-200), cell based potency assays utilizing various immunoassays (ELISA, ELLA, etc.) platforms, and or identification / characterization / potency assays using multicolor flow cytometry platforms. This position supports the ramp-up of QC analytical release assays and other activities in a newly built facility for cell therapy products. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to meet target turn around times.

Essential Functions and Responsibilities

• Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
• Act as a subject matter expert (SME) on one or more assays and train new laboratory personnel
• 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 product stability programs, including execution of stability testing and final reporting of stability data.
• Initiate and support revisions of documentation, such as SOP, protocols and reports.
• Initiate and support quality records such as deviations, laboratory investigations, CAPAs, and change controls
• Perform peer review of laboratory data and logbooks.
• Update trending data sheet, as required.
• Operate at a consistent and high level of efficiency, while producing high-quality and accurate results.
• Support Health Authority inspections.
• Provide input to functional laboratory team meetings.
• 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 miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Minimum of a bachelor’s degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience.
• Minimum two (2) years of GMP experience in the pharmaceutical industry within a Quality Control role.
• Solid understanding and functional knowledge with hands-on experience with at least one of the following: Multicolor Flow Cytometry, Cell-based ELISA, cell culture with cell enumeration (NC-200)
• Experience in technical writing (e.g., test methods, SOPs, protocols, etc.)
• Detail-oriented with strong technical skills
• High level of ownership and accountability
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

Preferred Education, Skills, and Knowledge

• Experience with cell therapy products is a plus and/or relevant technical skills (NC 200, ELISA, and/or Flow).

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 coveralls, 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 the scheduled workday which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 30 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 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 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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