Director, DPF Site Operations

Director, DPF Site Operations

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.

We're seeking a hands-on leader to manage day-to-day operations and operational oversight for our designated pathogen free (DPF) site operations for our Christiansburg VA location. You'll play a critical role in ensuring the production of high-quality organs for GMP use, including human transplantation. You have extensive experience in risk management activities and GMP compliance.

The Director, DPF Site Operations role is pivotal in maintaining regulatory compliance, upholding the highest quality standards, and driving operational efficiency. The Director ensures alignment and collaboration among key site functions—including Quality, Animal Care, Facilities Maintenance, and Materials Management—to drive operational success, meet project goals, and uphold the highest standards of compliance, efficiency, and innovation. Responsibilities include managing the site budget, reviewing and approving GMP documents, leading safety initiatives, and regulatory adherence. Additionally, this role champions a culture of collaboration, accountability, continuous improvement, and right-the-first-time execution to support the site's long-term success.

Responsibilities

• Direct and oversee all DPF site operations, ensuring adherence to regulatory requirements and quality standards
• Responsible for planning, direction and goal setting for the department/function in alignment with company milestones, and support the function's overall strategy
• Organize and lead projects that drive quality and compliance at the site
• Establish necessary policies, practices and programs for site, and review and approve site validation documents for compliance and accuracy
• Manage site budget and expenses and ensure efficient resource allocation
• Chair site Institutional Animal Care and Use Committee (IACUC) meetings to ensure ethical and regulatory compliance in animal care and use
• Author, review, and approve quality events, including change controls and deviations
• Lead safety initiatives at the site to maintain a secure and compliant working environment
• Collaborate with Quality and Regulatory teams to ensure continuous compliance with GMP and other regulatory standards
• Cultivate and maintain external relationships with third-party suppliers and partners, key customers, and professional organizations
• Lead and ensure collaboration of a cross-functional team to ensure project milestones are achieved on target
• Foster a culture of collaboration, quality, compliance, right-the-first-time execution, and continuous improvement at the site
• Collaborate with other DPF sites to help ensure a unified operational approach across sites
• Interact with regulatory authorities during facility inspections
• Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)

Minimum Requirements

• Education and Experience Requirements: Bachelor's degree in life science, engineering, or another related field, and 15+ years of biologics or pharmaceutical experience
• Master's degree in life science, engineering, or another related field, and 13+ years of biologics or pharmaceutical experience
• 8+ years of people management experience
• Experience leading teams in a GMP pharmaceutical or biotech production facility
• Experience interfacing with the U.S. Food and Drug Administration (FDA) and, as appropriate, ex/US regulatory agencies
• Strong knowledge of cGMP compliance and Quality

Preferred Qualifications

• Master's degree in life science, engineering, or another related field
• Experience and understanding of Xenotransplantation and/or organ transplantation

Job Location & Travel

This position will be a fully onsite role at the Christiansburg, VA location. This position will require travel of up to 10%.

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.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.