Manager, IT Manufacturing Business Operations

Overview

This position reports to the Executive Director, IT Manufacturing. The Manager, IT Manufacturing Business Operations is a "hands on" role that will function as the technical and operational lead for IT systems utilized at Iovance's manufacturing locations. This role will provide leadership and expertise within specialized fields of systems architecture, design, automation, management, validation, support and operation including aspects of the information management solution from an integration and/or process improvement perspective. As well as being an IT operational and application support subject matter expert, the role will partner with the functions (Manufacturing, Quality, Supply Chain, MSAT) to ensure IT delivers systems that enable 24x7 manufacturing operations and growth.

Essential Functions and Responsibilities

• IT system owner responsible for system life cycle management, validation, and operation of computer-based systems supporting 24x7 manufacturing operations, which includes Labvantage LIMS, Siemens Desigo Building and Environmental Management Systems and other systems supporting Manufacturing and Quality operations at Iovance's Manufacturing sites.
• As the system owner, responsible for planning, development, implementation, testing, deployment, operation, change control, compliance and documentation of system enhancements, upgrades, patches, integrations, and validation. Create, review, and approve technical documentation, protocols, and reports, including IQ/OQ/PQ protocols, change controls, and SOPs.
• Will lead and improve the IT team's operational activities (e.g. end-user support, break-fix, administration) of critical systems; this includes establishing service level agreements, streamlining procedures, overseeing vendors, monitoring/measuring effectiveness, troubleshooting and issue resolution.
• Develop a deep understanding of Iovance's manufacturing process/operations, create/maintain process, system, and data flows. Partner with business teams to execute continuous improvement initiatives that drive operational efficiencies, improve quality, and reduce cost
• Provide subject matter expertise of pharmaceutical business processes, validation, data integrity, data architecture, and technology to support clinical and commercial manufacturing.
• Provide support to a growing IT organization in the way of leadership and mentoring of team members.

Travel

• Minimal travel requirements (less than 5%)

Required Education, Skills, and Knowledge

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

Preferred Education, Skills, and Knowledge

• At least 8 years of relevant experience managing the system life cycle for applications in a pharmaceutical manufacturing environment with a strong understanding of pharmaceutical, manufacturing and equipment supporting cell therapy commercial and clinical manufacturing.
• Proven knowledge, skills and experience as a system analyst using formal system development life cycle methodologies optimized for implementation and validation of pharmaceutical manufacturing systems
• Project management skills to lead and manage system-based initiatives.
• Experience with Iovance's electronic systems including Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain).
• Experience transforming manual business operations into automated and integrated electronic systems.
• Strong working knowledge of cGMP, validation, 21 CFR Part 11, data integrity and good documentation practices
• Strong interpersonal, teamwork, presentation, and communication skills.
• Possesses a sense of urgency, can work independently, proactively identifies challenges, and takes the initiative to identify solutions.

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 job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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.

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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