Director, DPF Site Operations
United Therapeutics Corporation
Full-time
Remote friendly (Houston, TX)
United States
Operations
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Role Summary
Director, DPF Site Operations - manage day-to-day operations and operational oversight for designated pathogen free (DPF) site operations in Houston, TX, ensuring production of high-quality organs for GMP use and human transplantation. Lead risk management and GMP compliance, and drive regulatory adherence and operational efficiency.
Responsibilities
- Oversee day-to-day site operations for the DPF site in Houston, TX.
- Ensure production of high-quality organs for GMP use and human transplantation.
- Maintain regulatory compliance and uphold quality standards.
- Align and collaborate with Quality, Animal Care, Facilities Maintenance, and Materials Management.
- Manage the site budget and review/approve GMP documents.
- Lead safety initiatives and ensure regulatory adherence.
- Cultivate a culture of collaboration, accountability, continuous improvement, and right-the-first-time execution.
Qualifications
- Required: Bachelor’s degree in life science, engineering, or related field, plus 15+ years of biologics or pharmaceutical experience; or Master’s degree in life science, engineering, or related field, plus 13+ years of biologics or pharmaceutical experience.
- Required: 8+ years of people management experience.
- Required: Experience leading teams in a GMP pharmaceutical or biotech production facility.
- Required: Experience interfacing with the U.S. FDA and, as appropriate, ex/US regulatory agencies.
- Required: Strong knowledge of cGMP compliance and Quality.
- Preferred: Master’s degree in life science, engineering, or related field.
- Preferred: Experience and understanding of Xenotransplantation and/or organ transplantation.
Skills
- Leadership and people management
- GMP compliance and regulatory experience
- Quality management and risk assessment
- Cross-functional collaboration
- Budgeting and document review
- Safety leadership and operational excellence
Education
- Bachelor’s or Master’s degree in life science, engineering, or related field (as specified above)
Additional Requirements
- Location: Initially remote during site construction; eventual onsite role at Houston, TX.
- Travel: Approximately 25% in the first year; up to 10% long term.