Senior Process Technical Services Specialist

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 SeniorPTSSpecialist is a Manufacturing Operations cell therapy subject matter Specialist reports to theManagerPTSandis responsible forcontributing to deviation root cause analysis and owning steps of the manufacturingprocess oftech SeniorPTSSpecialist is also responsible for protocol and report authoringCo/lead techtransfer and ongoing technical support for manufacturing operationsand execution ofPTSlaboratory activities.

EssentialFunctions and Responsibilities

• Serve as a manufacturingprocessestechnical SMErepresentingPTSduring cross functional meetings.
• Serve asa primaryPTS point of contact for study clinical and commercial manufacturing execution escalations for multiple cell and gene therapy GMP processes.
• ProvidePTSoversight training and supportaswithin the manufacturing cleanroom environment as well as assist with onboard training of newPTSspecialists.
• Manage and own Technology Transfer campaignsofnew product introduction and process improvements to internal and external manufacturing facilities. Provide hands-on manufacturing process training to manufacturing personneland development of training materialsas part of process tech transfer as needed.
• SeniorPTSSpecialists maybe responsible forthe authoring collaborating approvingand the ownership/management of the following documentation:
• Quality Systems Change Control (tech transfer process improvement emergency etc.) Deviations/ LIRs(complex manufacturing investigations) CAPAs (complete ownership) Action Items (management and execution)
• Study or investigational protocols and corresponding reports
• Process Characterization Validation Qualificationprotocolsand reports
• Product Impact and Risk Assessments Failure Modes Risk Analysis
• SOPs COPsPTSMBRs
• Senior Specialists willbe responsible formanagingPTSdepartment Quality System metrics and managing complex investigations (CAPA Deviation etc.) related to the manufacturing process. Investigation activities may include execution of studies GEMBA Kaizen Risk Analysis etc.through tocompletion.
• Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Willassistmanufacturing and quality when authoring Master Batch Records and implementing process improvements.
• Analyze and interpret manufacturing process data and ensure process trends are addressed appropriately. Emphasize operational excellence and continuouslyidentifyprocess within the manufacturing operations environment.
• Execute hands on experiments in theiMAPslab (as applicable).
• Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
• Comply withSafety SOPs SDS sheets and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

RequiredEducation Skills and Knowledge

• B.S degree in a relevant discipline or equivalent industry experience.
• a minimum of 8 years of related experience with aBachelorsdegree; or 6 years and aMastersdegree; or a PhD with 3years experience; or equivalent experience(relevant hands-on operations experience for clinical or commercial production and/or process development experience)in the life sciences industry.
• Expertisein cell culture and aseptictechnique.
• Expertise inlaboratory execution.
• Previouscell therapy manufacturing process experiencerequired.
• Understanding small scale andfull scalemanufacturing.
• Knowledge and understanding of GMP systems within a manufacturing facility.
• Ability to organize analyze manufacturing process data and provide potential process improvements.
• Knowledge andexpertisein manufacturing process tech in prior manufacturing process tech transfer isrequired.
• Excellent oral and written communication skills. Strong technical writing abilityrequired.
• Ability to work cross functionally within the organization as part of a project team.
• Self-motivated and willing to accept temporary responsibilities outside ofinitialjob description.
• Must be comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

PreferredEducation Skills and Knowledge

• Complex understanding of cell biology and immunologypreviousTIL manufacturing experience preferred.
• Prior cell therapy experience is highly preferred.

The physical demands described hererepresentthose thatan employee must meetto perform the essential functions of this job successfully. Reasonable accommodations may be madeupon requestto enable individuals to perform essential contact Human Resources to requestan accommodation.

PhysicalDemands and ActivitiesRequired

• Must be able to move to and from the office to the lablocatedon separate floors and move about the office and lab as needed.
• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able tograsp withboth hands perform repetitious actions such as pinch with thumb and forefinger turn with hand/ arm and reach above shoulder height.
• Must be able touse several types of laboratory equipment and pipettes for extended periods.
• Must be able to work on a tablet or computer typing for 50% of a typical working day.
• Must be able to move and lift 20 pounds multiple timesdaily.
• Must be able to use near vision to view samples at close range.
• Wear proper personal protective equipment when in a laboratory setting i.e. safety glasses lab coats and closed-toed shoes.

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 officeanda laboratory setting. When in the labthere may be a risk of exposure to hazardous or biological waste within the environment through receipt transport storage preparation dispensing administration cleaning and/or disposal of contaminated areas and waste.

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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 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 .

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