Manager, Good Manufacturing Practice (GMP) Operations
UT Southwestern Medical Center, Dallas, TX
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.
- 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.
- 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.