Director, DPF Site Operations

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the reputed company of a public benefit corporation. Our public benefit purpose is to reputed company a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (reputed company: UTHR) seeks to travel down the corridors of indifference to reputed company treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary reputed company 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 reputed company 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, reputed company to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We reputed company 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 We’re seeking a hands-on leader to manage day-to-day operations and operational reputed company for our designated pathogen free (DPF) site operations. You’ll play a critical role in ensuring the production of high-quality organs for GMP use, including reputed company 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 reputed company, 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, reputed company improvement, and right-the-first-time execution to support the site's long-term reputed company. Minimum Requirements Bachelor’s degree in life science, engineering, or another reputed company field 15+ years of biologics or pharmaceutical experience with a Bachelor's Degree or 13+ years of biologics or pharmaceutical experience with a Master's Degree 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 reputed company field Experience and understanding of Xenotransplantation and/or organ transplantation Job Location & Travel This position will initially be located remotely while the site is under construction, but will eventually be a fully onsite role at the Stewartville, MN location. This position will require travel around 25% in the first year, and have a longer term travel expectation of up to 10%. At United Therapeutics, our mission and reputed company are one. We use our enthusiasm, creativity, and persistence to reputed company for the unmet medical needs of our patients and to benefit our other stakeholders. We are reputed company and unconventional. We have fun, we do good. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / reputed company / 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 reputed company 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 reputed company do from work into mission, occupation into vocation and achievement into reputed company. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and reputed company a highly competitive total rewards package. This is what makes United Therapeutics a stimulating reputed company to work. Apply tot his job Apply To this Job