Manager, IT Manufacturing Systems

Overview

This position reports to the Executive Director, IT Manufacturing.  The Manager, IT Manufacturing Systems is a “hands on” manager role that will function as the technical and operational lead for IT systems utilized at the Iovance’s manufacturing locations with primary responsibility for the Emerson Syncade Manufacturing Execution System (MES) supporting inventory management, eLogbooks and dispensing with future plans for Electronic Batch Records (EBR).   The role’s expertise within manufacturing, quality and supply chain information systems will be paramount in continuing digitalization of the Iovance manufacturing site to drive quality, scale production, and lower costs.  As well as being an operational and application support subject matter expert, the role will partner with the functions (Manufacturing, Quality, MSAT) to ensure IT at Iovance is planning, delivering, and maintaining systems the business needs.

Essential Functions and Responsibilities

• Lead selection, deployment, validation, and operation of computer-based systems for 24x7 manufacturing, laboratory and quality management applications, with a primary focus on leveraging IT solutions for compliant and efficient manufacturing operations at Iovance’s Philadelphia site.
• Design, management, and documentation of application and data architectures for Manufacturing Systems.
• Perform role of system owner and subject matter expert for our Emerson Syncade Manufacturing Execution System (MES), leading support, enhancements, and projects to leverage the platform including a major initiative to migrate master batch records to electronic processing.
• Operational activities (e.g., end-user support, break-fix, sustaining compliance) of critical systems including MES, Laboratory Information Management System (LIMS) and Building Management Systems. This includes monitoring, application patch/release management, system backup/recovery, system administration, troubleshooting, change control, deviation and CAPA management, and issue resolution.
• Partner with business teams to map business processes, drive continuous improvement, and implement system enhancements that provide operational efficiencies and cost reductions.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

Travel

• Potential travel up to 10%

Required Education, Skills, and Knowledge

• Bachelor's degree (preferably Computer Science/Engineering)

Preferred Education, Skills, and Knowledge

• At least 10 years of hands-on experience working in the biotech/pharma industry implementing and supporting operations of information technology systems; experience with cell and gene therapy manufacturing is preferred.
• Extensive experience implementing and administering manufacturing executions systems (MES), specifically Emerson Syncade Order and Inventory Management, Equipment Tracking, Workflow and Electronic Batch Records.
• Strong working knowledge of the systems development life cycle and its integration with GMP computer system validation (CSV) with the ability to author CSV documents and manage quality deviations, CAPAs and change controls.
• Knowledge, skills and experience as a project manager or a lead project role managing activities, timelines, and resources (both internal and external) to meet targets.
• Experience with Iovance’s other Manufacturing Systems including Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain) is a plus.
• Strong collaboration, interpersonal, presentation and communication skills.
• Possess a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions and act.
• Can work as an effective team member as well as independently.

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 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 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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s duties 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

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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