Manager of Good Manufacturing Practice (GMP) Operations, UT Southwestern

Manager, Good Manufacturing Practice (GMP) Operations

UT Southwestern Medical Center, Dallas, TX

Full-Time

Take advantage of this opportunity to join UT Southwestern Medical Center – ranked one of the “Best Places to Work” by the Dallas Business Journal. Due to our continued growth, UT Southwestern Medical Center is seeking a Manager of Good Manufacturing Practice (GMP) Operations.

Job Duties:

  • Lead the establishment and execution of laboratory processes (including upstream process, harvest, and chromatography-based purification) for the production of AAV vector products to supply material for pre-clinical and clinical studies.
  • Author technical reports, tech transfer documents, and prepare scientific presentations as needed; write/revise SOPs as needed.
  • Compliance with U.S. FDA Regulation 21CFR Part 210, 211, and 820 as well as ISO 13485. Keep current with FDA Regulations, procedures, and policies as necessary.
  • Coordinate internal production requirements and prioritization.
  • Regularly interface with internal program leads to assess and forecast material supply requirements, coordinate operations schedule in order to supply material in a timely fashion.
  • Communicate production schedule and priority to internal stakeholders on a regular basis.
  • Identify further opportunities for optimizing process.
  • Mentor others and lead lab activities to troubleshoot process with scientists in the lab.
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner.
  • Performs other duties as assigned.

Requirements:

  • BS in Biological Sciences, Biochemistry, Immunology, Virology, (Bio)Chemical engineering or related field with 8+ years, MS with 6+ years, or a Ph.D. with 2+ years of cGMP operations, relevant academic and pharmaceutical experience, or an equivalent combination of education and experience, are acceptable.
  • Experience and expertise in the cGMP manufacturing, preferably biological material. Preferably, familiarity with multiple lab-scale upstream process platforms for cultivating mammalian cells and producing viral products in a high paced, high throughput environment.

This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information

To learn more and to apply, please visit: https://jobs.utsouthwestern.edu/pracgmp

About UT Southwestern Medical Center:

UT Southwestern Medical Center ranks among the top academic medical centers with more active Nobel Prize winners than any other medical school in the world. As a premier educational, clinical and research institution, UT Southwestern is home to more than 2,000 distinguished scientists, physicians and allied health professionals. Our University Hospital has achieved Magnet Recognition® by the American Nurses Credentialing Center (ANCC), joining only 7% of hospitals in the United States.

UT Southwestern is an Affirmative Action/Equal Opportunity Employer. Women, minorities, veterans, and individuals with disabilities are encouraged to apply.