Job Information
United Therapeutics Lead Project Manager, Manufacturing Business Operations in Durham, North Carolina
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
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 Lead Project Manager, Manufacturing Business Operations plans and manages internal engineering projects, tech transfer and change control activities, new equipment procurement and capital expansion projects from initiation through completion. This role will also lead technical and program management support for manufacturing initiatives, process development and improvements, implementation of new technologies, budget management and third-party oversight.
Provide project management of assigned strategic programs
Plan, coordinate, and manage multiple large-scale SAP ERP projects of high complexity
Lead or coordinate capital expansion and engineering project planning, resourcing, supply and subcontract management and progress reporting
Monitor project milestones and liaise with other internal/external stake holders to ensure project stays on schedule
Lead tech transfer activities associated with relocating manufacturing process from existing facility to new facility as well as any post-start up change control activities
Coordinate internal review/approval of new equipment procurement, documentation, and deliverable schedule
Prepare technical reports and project documentation for assigned projects of increased complexity
Prepare and independently manage assigned budgets, timelines, and associated activities
Prepare legal and purchasing documentation for vendors/suppliers (NDAs, SOWs, PO requests, Vendor/Material Set Up, Forecasts) as well as manage approvals
Assist in the negotiation of service and supply agreements
Write regulatory support documentation within the UT common technical document framework
Participate in due diligence and investor relations activities
Other related responsibilities as assigned
For this role you will need
Minimum Requirements
Bachelor’s Degree in science or engineering
8+ years of pharmaceutical/biotechnology operations or product development experience with a Bachelor's Degree or
6+ years of pharmaceutical/biotechnology operations or product development experience with a Master's Degree
Strong knowledge of biotechnology/pharmaceutical production systems
Ability to work independently
Excellent communication and organizational skills
Proficient with Microsoft Office applications
Preferred Qualifications
Master’s Degree in science, engineering, or business
2+ years of SAP experience
Certified Project Management Professional (PMP)-PMI
Experience with regulatory requirements
Experience with GxP systems (Trackwise, MasterControl) and SAP
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.
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
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.
United Therapeutics
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