Director, DPF Site Operations jobs in United States
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United Therapeutics Corporation · 8 hours ago

Director, DPF Site Operations

United Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies for organ transplantation. The role of Director, DPF Site Operations is critical for managing day-to-day operations, ensuring regulatory compliance, and driving operational efficiency at the designated pathogen free site.

BiotechnologyPharmaceuticalTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

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)

Qualification

GMP complianceBiologics experiencePharmaceutical experiencePeople managementFDA interactionXenotransplantation knowledgeQuality assuranceContinuous improvementRisk managementCollaboration

Required

Bachelor's degree in life science, engineering, or another related field, and 15+ years of biologics or pharmaceutical experience
Master's degree in life science, engineering, or another related field, and 13+ years of biologics or pharmaceutical experience
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

Master's degree in life science, engineering, or another related field
Experience and understanding of Xenotransplantation and/or organ transplantation

Benefits

Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
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Company

United Therapeutics Corporation

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Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.

H1B Sponsorship

United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (8)
2022 (6)
2021 (9)
2020 (4)

Funding

Current Stage
Public Company
Total Funding
unknown
1999-06-17IPO

Leadership Team

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Hamlet Bonilla Evertsz
Senior Network Engineer
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Company data provided by crunchbase