What are the responsibilities and job description for the Director, Operational Technology position at Lensa?
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California, US residents click here (https://www.unither.com/docs/UNITHER Applicant Notice - (12-22-23) Final 2.15.24 Combined EN and French.pdf#page=9) .
Who We Are
The job details are as follows:
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.
Who You Are
You're excited to be counted on as a leader within our Operational Technology group while still being ready and willing to roll up your sleeves and get hands-on at a moments notice. The Director, Operational Technology will provide strategic leadership and management of Operational Technology professionals supporting manufacturing, automation, and quality systems within a regulated, validated environment. This role will lead and develop a multidisciplinary team of professional and support staff, fostering technical excellence, continuous improvement, and a strong culture of accountability and collaboration. The Director will execute the OT vision and roadmap, ensuring reliable, compliant, and scalable technology solutions across manufacturing, quality, and manufacturing support platforms. They will partner closely with cross-functional stakeholders—including Manufacturing, Quality, Engineering, IT, and Business Leadership—to align technology strategy with enterprise objectives and enable operational growth. This position will be responsible for setting priorities, allocating resources, and managing execution across multiple initiatives while balancing day-to-day operational support with short- to medium-term strategic planning. The Director will drive standardization, innovation, and risk-based decision-making, ensuring systems meet regulatory requirements while advancing automation, data integration, and digital transformation initiatives.
Minimum Requirements
United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. Approximately 10% travel is expected for this position.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
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
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.
If you have questions about this posting, please contact support@lensa.com
California, US residents click here (https://www.unither.com/docs/UNITHER Applicant Notice - (12-22-23) Final 2.15.24 Combined EN and French.pdf#page=9) .
Who We Are
The job details are as follows:
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.
Who You Are
You're excited to be counted on as a leader within our Operational Technology group while still being ready and willing to roll up your sleeves and get hands-on at a moments notice. The Director, Operational Technology will provide strategic leadership and management of Operational Technology professionals supporting manufacturing, automation, and quality systems within a regulated, validated environment. This role will lead and develop a multidisciplinary team of professional and support staff, fostering technical excellence, continuous improvement, and a strong culture of accountability and collaboration. The Director will execute the OT vision and roadmap, ensuring reliable, compliant, and scalable technology solutions across manufacturing, quality, and manufacturing support platforms. They will partner closely with cross-functional stakeholders—including Manufacturing, Quality, Engineering, IT, and Business Leadership—to align technology strategy with enterprise objectives and enable operational growth. This position will be responsible for setting priorities, allocating resources, and managing execution across multiple initiatives while balancing day-to-day operational support with short- to medium-term strategic planning. The Director will drive standardization, innovation, and risk-based decision-making, ensuring systems meet regulatory requirements while advancing automation, data integration, and digital transformation initiatives.
- 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
Minimum 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
- 15 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
- 8 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
- Certified Project Management Professional (PMP)-PMI
United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. Approximately 10% travel is expected for this position.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
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
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.
If you have questions about this posting, please contact support@lensa.com