Laboratory Systems Specialist [Contract]

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 Laboratory Systems Specialist will fill a critical role at Iovance’s Philadelphia manufacturing facility and office. The ideal candidate will possess excellent technology troubleshooting, communication and customer service skills. The position will spend majority of the time helping with IT needs in the laboratory and manufacturing cleanroom areas maintaining operations as well as equipment and system data integrity.

Rotation schedule:

Week 1: Sunday to Wed from 7am-6pm

Week 2: Sunday to Tuesday from 7am-7pm

Specific Responsibilities

• Act as IT administrator on various IT systems in laboratory areas, including areas operating to the standards of Good Manufacturing Practices (GMP), and assist with tasks such as setting up systems, users, roles, access levels, user onboarding training, etc.
• Provide tier-2 support of application incidents reported through the help desk in the laboratory systems.
• Work with application vendors and provide assistance to resolve application issues, maintenance items, and enhancement requests.
• Perform daily monitoring of laboratory and R&D applications in production use.
• Lead small to medium complexity software upgrade initiatives or enhancements to workflows including the design, build, and test phases.
• Implement changes using documented procedures that are compliant with each department's policies and procedures.
• Take ownership of operational issues and act as a liaison between customer and other support staff to facilitate resolution.
• Ensure data is backed up appropriately in the laboratory systems.
• Work with business users in developing test cases for new or enhanced department applications. Builds relationships with the business users and presents ideas clearly and concisely.
• Participate in the installation and support of hardware and peripherals.
• Become a member of the after-hours and on-call support staff, maintaining minimal operational downtime for the 24x7 manufacturing site.
• Anticipates problems, provides solutions to complex problems with the necessary priorities, and presents the solution to the business partners.
• Perform or participate in analysis of systems/applications/databases and in the coordination of implementation and maintenance plans, including troubleshooting issues.
• Assist in developing department education materials and training of core users of the current laboratory system.
• Serve as primary IT contact for the laboratory and clean room systems, ensuring both vendor and internal activities are on track through well-defined action plans and communication.

Qualifications

• Minimum of 2 years of managing IT systems in a laboratory setting in the pharmaceutical and biotechnology industry.
• Documented experience in supporting Laboratory Information Systems preferred.
• Knowledge and experience with GMP, quality systems and regulatory standards requirements in the pharmaceutical and biotechnology
• Able to don cleanroom garments and personal protective equipment (scrubs, gowning coverall, sterile boots, masks, gloves, goggles) aseptically and work in a clean room environment for extended periods of time.
• Strong Microsoft Office skills (Outlook, Word, Excel, PowerPoint, etc.).
• Strong Break / Fix skills with desktops, workstations, notebooks, printers and handhelds.
• Broad experience of IT with strong understanding of networks, servers and telecoms.
• Ability to provide consistent, excellent customer service to entire staff, representing a variety of personalities and management levels.
• Excellent written, verbal communication skills and presentation skills.
• Must have the ability to mentor or share best practices with other members of the team.
• Must be detail oriented and self-motivating.
• The ability to work in a flexible, team-oriented environment is required.
• Working knowledge of IT Service Management framework and/or ITIL concepts and practices.
• Ability to lift/move computer equipment weighing up to 50 Lbs.
• Ability to work on flexible hours to support business needs.

Desired

Validation experience to FDA CFR 21 Part 11 requirements. Ability to support a GxP environment with related GMP procedures.

Knowledge of Network Infrastructure and Identity and Access Management.

Preferred/Desirable Knowledge, Skills, and Education

• College degree: BS in Computer Science or Information Systems.
• 2-3 years experience supporting IT/Lab Automation Equipment and applications.
• Work on shift/On call basis as needed.

 

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 remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

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 job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

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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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