Associate Director, Operational Technology

United Therapeutics Corporation•Raleigh, NC

64d•Onsite

About The Position

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. You're passionate about Operational Technology (OT) in the pharmaceutical industrial and excited about the opportunity to support our growing facilities across the organization. You have a wide breadth of experience in OT and are comfortable being hands-on to remove technical hurdles from our GxP Systems, SAP, and Automation & Control teams. The Associate Director, Operational Technology will provide leadership and management of Operational Technology professionals focused on manufacturing, automation, and quality systems. They will lead a team of professional and support staff and ensure the ongoing development of the team. The Associate Director, Operational Technology will maintain a strategic approach to technology and automation support for various manufacturing, quality, and manufacturing support systems in a regulated, validated environment. This role will plan and manage team priorities and allocate resources to align with business objectives, and they will build relationships and engage key stakeholders in cross-functional projects.

Requirements

Bachelor's Degree in Information Technology, Chemical Engineering or BioEngineering or an applicable scientific and/or engineering discipline preferred, will consider commensurate experience and/or combination of education and experience
12+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on SAP, Laboratory Information Management Systems (LIMS) systems, Chromatography Data Systems, Electronic Lab Notebooks (ELN), and/or Enterprise Document Management (EDM) systems
6+ years of people management experience
Strong people leadership and management expertise, and demonstrated competency in the management of complex staff and organizational issues
General management administrative skills (budgeting, resource allocation, etc.)
Excellent project management skills
Effective leadership, and strong verbal, presentation, and technical writing skills
Superior database maintenance / development experience
Computer hardware / software validation and change control experience
Ability to interface with external and internal resources at all levels
Broad knowledge of the regulatory requirements for pharmaceutical applications
Working skills and experience with PLCs, DCSs, Batch Operations (S88/S95), SCADA, MRP, IT, and OEM equipment
Experience in the design, implementation, and maintenance of large-scale information systems (MRP, MES, LIMS) to support regulated FDA pharmaceutical manufacturing operations
A broad knowledge and practical experience of computer, equipment, and application validation (GAMP methodology), cGMPs, and 21 CFR Part 11

Nice To Haves

Certified Project Management Professional (PMP)-PMI

Responsibilities

Lead, guide, and develop the Operational Technology (OT) team, including but not limited to mentoring, setting goals, supporting career development, and providing ongoing training
Build and maintain a highly motivated team of engineers and technicians to ensure optimum technical support for manufacturing and quality systems
Provide oversight of OT projects, monitor progress, manage resources, and maintain timelines
Manage engineers, technicians and external contractors during system development, fabrication, installation, and start-up activities
Provide strategic and tactical management guidance as a key liaison between Manufacturing, Quality and Management in relation to process automation and information technology systems
Develop, implement and drive OT departmental and interdepartmental strategic objectives
Provide multi-site resource and system administration/management including Research Triangle Park, Silver Spring, Beltsville, and other identified strategic sites
Perform troubleshooting of challenging equipment / automation issues to improve manufacturing performance and maintenance of the automation systems in compliance with cGMPs
Provide technical input, as required, for regulatory submissions and agency queries
Ensure plant preventive maintenance, metrology, security and programs are functioning effectively and meet regulatory and outside agency compliance requirements
Evaluate and recommend software, hardware, and vendors. Conduct vendor audits as required.
Establish and manage adherence to departmental budgets, schedules, work plans and performance requirements through effective measurement tools

Benefits

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

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