Quality Control Training Specialist, Microbiology

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  The Quality Control Training Specialist will support quality control training at Iovance’s integrated Cell Therapy Center (iCTC).  The Quality Control training programs include, but are not limited to, in-process, final drug product, and stability testing with a focus on cell therapy products.

The Quality Control Training Specialist, Microbiology will support quality control microbiology and environmental monitoring training at Iovance’s Cell Therapy Center (iCTC and/or iPBMC manufacturing site (IOVA-A).  The quality control training programs include in-process and final drug product microbial testing 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

• Act as subject matter expert (SME) and train new laboratory personnel.
• Train staff on environmental monitoring of the cleanroom areas and growth promotion of microbiological media.
• Lead classroom training for Grade B gowning, perform gowning qualifications, and annual gowning qualification.
• Train staff on gram stain, endotoxin, sterility testing and mycoplasma testing.
• Support technical problem-solving issues pertaining to GMP Quality Control
• Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls.
• As needed to support production, perform GMP Quality Control laboratory testing and environmental monitoring 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 peer review of laboratory data and logbooks.
• 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.
• 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 three (3) years of experience in the pharmaceutical industry within a Quality Control role
• Strong ability to develop training materials, conduct training sessions, and evaluate the effectiveness of training programs
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skill
• 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
• Previous experience with GDP, GLP, GMP.
• Excellent written and verbal communication skills for creating training documents, presenting information clearly, and guiding trainees effectively

Preferred Education, Skills, and Knowledge

• Advanced degree (MSc. preferred.)
• 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 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 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, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.
• 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.com.

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