Overview

Iovance Biotherapeutics is seeking a Senior Quality Control (QC) Analyst to join the team at Co-located at the American Red Cross Penn Jersey Region, this Iovance facility produces a critical raw material used in the company’s TIL process. The critical raw material is processed from leukapheresis units and frozen.

The QC Analyst will support quality control microbiology testing operations at Iovance’s 700 Spring Garden St, Philadelphia, PA. The quality control microbiology testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, compressed gas monitoring, and/or sterility techniques.

Specific Responsibilities

• Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
• Perform environmental monitoring of the cleanroom areas as scheduled.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.

• Perform all activities with respect to cGMP compliance.

• Support thorough cGMP investigations for out-of-specification test results.
• Support technical problem solving.
• Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.

Education and Qualifications

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum 5 years of experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.
• 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.

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