Senior Quality Control Analyst Lab Technical Support Analytical

Overview

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

This role requires handson laboratory experience in at least two 2 of the following areas: cell culture / maintenance and cell count determination (NC200 cellbased potency assays utilizing various immunoassays (ELISA ELLA etc. platforms and/or identification / characterization / potency assays using multicolor flow cytometry platforms. This position will support the onboarding of new or updated assays for the QC analytical team and other activities in a newly built facility for cell therapy products. 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 coqualification validation and technical transfer of updated and new assays as well as potential new products.
• Act as subject matter expert (SME) and train 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 ensuringtesting 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

• Bachelors 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 handson experience with two 2 or more of the following: Multicolor Flow Cytometry Cellbased ELISA cell culture with cell enumeration (NC200
• 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 multidisciplined teams
• Extremely detailoriented 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 and/or relevant technical skills (NC 200 ELISA and/or Flow).

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.

Physical Demands and Activities Required:

• Must be able to wear all appropriate Personal Protective Equipment (PPE) including but not limited to: lab coat half face respirator as applicable safety glasses/goggles and nitrile gloves.
• 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 20 pounds.

Mental:

Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated 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.

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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 e.

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