Director DPF Operations

California, US residentsclick here.

The job details are as follows:

Who We Are

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 ready to put your leadership experience into action, overseeing daily operations and driving operational excellence at our designated pathogen free (DPF) facility. You will play a critical role in ensuring the production of high-quality organs for GMP use, including human transplantation. Bringing together Quality, Animal Care, Facilities Maintenance, and Materials Management, you will align teams, resources, and priorities to achieve project milestones, strengthen safety and compliance, and drive operational efficiency.

The Director, DPF Site Operations role is pivotal in maintaining regulatory compliance, upholding the highest quality standards, and driving operational efficiency. 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.

• 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)
• Other duties as assigned

Minimum Requirements

• Education and Experience Requirements:
  • Bachelor’s degree in life science, engineering, or another related field and 15+ years of experience in biologics pharmaceuticals, swine production, or biomedical animal facility operations, with demonstrated responsibility for quality, compliance, and operational performance, or
  • Master’s degree in life science, engineering, or another related field and 13+ years of experience in biologics pharmaceuticals, swine production, or biomedical animal facility operations, with demonstrated responsibility for quality, compliance, and operational performance
• 8+ years of people management experience
• Experience leading teams in a GMP pharmaceutical or biotech production facility, or in swine production or biomedical animal operations with rigorous biosecurity, documented procedures, training, and audit requirements.
• Experience supporting inspections or audits and addressing findings in a regulated production or animal-care environment
• Strong knowledge and demonstrated application of quality systems, procedural compliance, controlled documentation, investigation of operational issues, and corrective actions
• Experience leading collaboration across cross-functional teams
• Education, experience, and documented results in leadership and project management
• Experience in problem solving, negotiations, presentation and collaborative team-building with non-direct reports across multiple geographies and cultures, as well as external parties
• Proficient with Microsoft Office software suite

Preferred Qualifications

• Master’s degree in life science, engineering, or another related field
• Direct FDA or international health-authority inspection experience
• Strong knowledge of cGMP and experience applying pharmaceutical quality systems.
• Experience and understanding of Xenotransplantation and/or organ transplantation

Job Location

This position is located 100% onsite at our Christiansburg, VA facility.

The salary range for this position is $171,500 - $210,000/yr and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

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.