Senior Quality Control Analyst, Lab Technical Support, Microbiology

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  The Senior Quality Control Analyst, Lab Technical Support, Microbiology will support quality control technical support testing and related activities at Iovance’s integrated Cell Therapy Center (iCTC).  The Quality Control technical programs include, but are not limited to, assay co-qualification, assay validation, and assay technical transfer with a focus on cell therapy products.

The Senior Quality Control Analyst, Lab Technical Support, Microbiology will support quality control microbiology and environmental monitoring technical support testing at Iovance’s Cell Therapy Center (iCTC).  The quality control microbiology programs include in-process and final drug product microbial assays such as bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. This position works across different shifts. Depending on your assigned shift, you may be required to work weekends and holidays to complete assigned work.

Essential Functions and Responsibilities

• Collaborate effectively with Iovance Development and ASAT teams to perform assay co-qualification, validation, and technical transfer of updated and new assays, as well as potential new products.


• Act as subject matter expert (SME) and train new laboratory personnel on assays.

• Perform all activities with respect to GMP/GDP compliance.


• As needed to support production, perform 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.


• Support thorough GMP investigations for quality events.


• Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures.


• Support technical problem solving for issues pertaining to GMP Quality Control.


• Assist in the generation and revisions and review of documentation, such as SOP, protocols and reports.


• Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.


• Perform technical review of laboratory data and logbooks.


• Operate at a consistent and high level of efficiency, 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.


• Other responsibilities, as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience.


• Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control or related role

• Solid understanding and functional knowledge with hands-on experience with two (2) or more of the following: endotoxin, mycoplasma, bioburden, sterility.


• Experience in technical writing (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls, etc.)


• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.

• Successfully interface with multi-disciplined teams


• Extremely detail-oriented with strong technical skills.


• High level of ownership and accountability.


• Demonstrate 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.

Physical Demands and Activities Required:

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.

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, 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 a work day 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 45 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 lab setting. When in the lab, you may be exposed to various chemical/biochemical exposures, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors.

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.

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