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Job Details

Associate VP Xeno and Regenerative Medicine Operations

Company name
United Therapeutics Corporation

Location
Durham, NC

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Job Description
The Job Details are as follows:\r
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OverviewIn continuing our mission to support Medicines for Life, we are expanding our operations facility at our Research Triangle Park (RTP), North Carolina campus. As part of this expansion, we are looking for an Associate Vice President of Xeno and Regenerative Medicine Operations. In this role, you will be responsible for providing executive leadership of operations for manufacturing organs for human transplantation to support our clinical trials, and subsequently commercial demand.\r
Key Accountabilities/ResponsibilitiesDesign, construct and qualify manufacturing facilitiesManage manufacturing of human transplantable organsManage annual operating costs within approved budgetsCollaborate with Quality and Regulatory teams, as needed, to ensure continuous supply of organsProvide strategic/tactical direction to all manufacturing operations and reporting functionsCultivate and maintain external relationships with third-party suppliers and partners, key customers and professional organizationsNegotiate favorable and sustainable agreements with key vendors and suppliersDevelop and lead strategic initiatives to drive continuous improvement and operational efficienciesSupport development efforts with innovative inputs and manufacturing resources to ensure project milestones are achieved on targetDevelop capacity planning strategy/model leveraging existing electronic systems for improved prediction of resource needsWill lead a staff of 2-3 direct reports consisting of Directors in the manufacturing organizationAbility to travel as needed up to 30%Other deliverables as required\r
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Minimum Qualification RequirementsBachelor’s degree in Life Science, Engineering, or another related field12 years biologics, pharmaceutical or Xeno tissue manufacturing experience7 years management experience, with 3-5 years of that experience in a Director capacityStrong knowledge of cGMP compliance and qualityExperience interfacing with the U.S. Food and Drug Administration (FDA) and, as appropriate, ex/US regulatory agenciesMicrosoft Office software suite\r
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Preferred Knowledge, Skills, and AbilitiesMaster’s in Engineering, MBA, or another related fieldExperience and understanding of Xeno tissue productionExperience with designing and qualifying GMP production facilitiesEducation, experience and documented results in leadership and project managementExperience in problem-solving, negotiations, presentation and collaborative team-building with non-direct reports across multiple geographies and cultures, as well as external parties\r
United Therapeutics  Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

Company info

United Therapeutics Corporation
Website : http://www.unither.com

Company Profile
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

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