The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you’ll contribute The role of the Associate Director, Upstream/Downstream, Dry Powder Inhalation is responsible for overseeing manufacturing operations of the dry powder inhalation product, ensuring adherence to regulatory standards and driving process improvement in RTP, NC. This includes leading a skilled manufacturing team that supports the upstream and downstream aspects of the commercial DPI operation. This role requires strong leadership skills, expertise in dry powder inhalation manufacturing, and a focus on continuous improvement and compliance. Manage the daily activities of the upstream and downstream DPI manufacturing process for a facility that will operate 24/7 Support senior and executive management in staffing the manufacturing facility Deliver product that meets quality and production standards on time and within budget Oversee upstream and downstream personnel scheduling Effectively communicate production needs and/or issues with senior management Collaborate with managers in other departments to effectively resolve manufacturing issues Collaborate with maintenance and engineering teams to address any equipment or facility-related issues Review/approve SAT, IOQ, PQ and PPQ validation documents related to upstream/downstream activities Review/approve departmental deviations, investigations, change controls, and CAPAs related to upstream/downstream issues Continuously evaluate and improve upstream/downstream manufacturing processes to enhance efficiency, productivity, and product quality Drive continuous improvement initiatives, including the implementation of new technologies, process optimization, and employee training for upstream/downstream Provide strong leadership to the manufacturing team, fostering a culture of collaboration, accountability, and continuous improvement Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary For this role you will need Minimum Requirements Associates Degree in a scientific discipline or a related field 12 years of experience in cGMP pharmaceutical manufacturing environment 5 years of people management experience and Valid Passport Must possess excellent written and oral communication skills Ability to apply GMP to company specific processes and products Ability to objectively, accurately, and thoroughly convey complex issues in writing; ability to produce a large volume of written materials independently Ability to interact with other departments effectively Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to manufacturing requirements Ability to handle confidential company data, information, etc. Microsoft office or equivalent Preferred Qualifications Bachelor’s Degree in a scientific discipline or a related field 7 year of people management experience At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / 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.