Manager, Good Manufacturing Practice (GMP) Operations

Employer
UT Southwestern Medical Center
Location
Dallas, Texas
Posted
Jul 31, 2018
Ref
41052
Required Education
Bachelors Degree
Position Type
Full time

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/gmpop

 

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.