Lead Quality Control Analyst - Dynamic Team

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  The Quality Control Analyst will support 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. We are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of   cell-based potency and identification assays using various immunoassay (ELISA, etc.) and flow cytometry platforms. This position will support the ramp up of QC and other activities in a newly built facility for cell therapy products.

Essential Functions and Responsibilities

• Act as a technical subject matter expert (SME) for potency and flow testing activities and train new laboratory personnel
• 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.
• Perform all activities with respect to GMP/GDP compliance.
• Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls
• Support thorough GMP investigations for out of specification test results and other quality events (initiate DRs and LIRs)
• Support technical problem solving for issues pertaining to GMP Quality Control
• Support product stability programs including execution of stability testing and stability data analysis
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• Perform peer and/or technical review of laboratory data and logbooks
• Analysis of assay-specific analytical performance trending
• Support Health Authority inspections
• Provide input to functional laboratory and cross functional team meetings
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results
• Other responsibilities as assigned

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum three (3) years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus.
• Experience with Flow Cytometry and Cell based ELISA platforms
• Successfully interface with multi-disciplined teams.
• Extremely detail-oriented with strong technical 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.

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 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 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].

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