Senior Specialist, Quality Control Lab Technical Support - Analytical

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-Analytical will support flow cytometry and potency method qualification/validation, method technical transfer, and product release testing at Iovance’s integrated Cell Therapy Center (iCTC). 

This role requires hands-on laboratory experience in at least two (2) of the following areas: cell culture / maintenance and cell count determination (NC-200), cell-based potency methods utilizing various immunoassay platforms (ELISA, ELLA, etc.), and/or identity / characterization / potency methods using multicolor flow cytometry platforms. This position will support the onboarding of new, or updating of existing, methods for the QC analytical team for release testing of cell therapy products. You may be required to work occasional weekends and holidays to complete assigned work.

Essential Functions and Responsibilities:

• Collaborate effectively with the Iovance Analytical Development (AD) and Analytical Sciences and Technology (ASAT) departments to perform assay qualification, validation, and technical transfer of updated and new methods.
• Act as subject matter expert (SME) and train laboratory personnel on new and revised methods.
• As needed to support product release, perform GMP laboratory testing with minimal to no errors, while ensuring testing is completed and documented in compliance with all applicable procedures, standards, and GMP/GDP regulations.
• Author, review, and approve technical documents including but not limited to protocols, reports, and SOPs.
• Contribute ideas for process improvements and technology enhancements in the QC laboratories.
• Support thorough GMP investigations for quality events (e.g. deviations, invalid assays, OOS).
• Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.
• Perform technical review of laboratory data and logbooks.
• Support Health Authority inspections.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Other responsibilities as assigned. 

Required Education, Skills, and Knowledge

• Degree in Biology, Immunology, Microbiology, Molecular & Cell Biology, or related scientific field, with 8 (Bachelor’s), 6 (Master’s) or 3 (Ph.D.) years of relevant experience.
• Minimum of three (3) years of GMP experience in the pharmaceutical industry within Quality Control or related function (e.g. AD or ASAT).
• Solid understanding, functional knowledge, and hands-on experience with two (2) or more of the following: multicolor flow cytometry, cell-based potency, or cell culture with cell enumeration (NC-200).
• Experienced technical writer (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls)
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multi-disciplined teams.
• Operate at a consistent and high level of efficiency, producing high quality and accurate results.
• Extremely detail-oriented with strong technical laboratory 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)
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. 

Preferred Education, Skills, and Knowledge

• Experience with cell therapy products.

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 wear appropriate lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• 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 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 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.

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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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