Senior Analyst, Quality Control Microbiology – Microbial ID

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering 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. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Senior Quality Control Analyst in Microbial ID Team supports Iovance’s Cell Therapy Center (iCTC) quality control testing operations.  The quality control testing programs include in-process and final drug product microbial testing such as Endotoxin, Gram Stain, Mycoplasma Testing, Microbial Identifications and Sterility techniques. This work shift is from Wednesday to Saturday. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the testing process is completed. Applicants must have experience in Microbial Identification.

Essential Functions and Responsibilities:

• Lead Microbial Identification testing function
• Lead Microbial Banking related Initiatives
• Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
• Perform all activities for cGMP compliance.
• Lead thorough cGMP investigations for out-of-specification test results.
• Lead technical problem-solving.
• Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
• 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

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum eight (8) years of experience in the pharmaceutical industry within a Quality Control role
• Skills and knowledge in performing microbial ID testing
• 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 a sense of urgency; ability to recognize time sensitivity.

Preferred Education, Skills, and Knowledge

• Experience with cell therapy products is a plus.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required:

• Must be able to work in a lab setting with biohazards / various chemicals.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing up to 45 pounds

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

This position will work in both an office and a QC laboratory 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.

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