Full Job Description
This role will be a Subject Matter Expert in the assigned
manufacturing process area (i.e. Cell Growth, Harvest, Filtration etc.); assume
the lead role during manufacturing operations.
Collaborate with Leadership team to determine equipment and
materials the suite will need to purchase in order to run the process. Work
with customer SMEs to transfer in and maintain customers' processes in
Experience and Education
1. PhD degree with 3 years’ experience in
biotech/biopharma industry (or equivalent) in the development and
characterization of mammalian cell culture processes.
2. Master's degree with 6+ years of
postgraduate experience in biotech/ biopharma industry (or equivalent) in the
development and characterization of mammalian cell culture processes.
3. Advanced experience in upstream
bioprocessing in a laboratory setting, including knowledge of state-of-the-art
equipment and industrial cell culture. Demonstrated ability to drive for
results and generate innovative solutions with minimum supervision. Mastery of
lab scale bioreactor systems and work with computerized process control
equipment. Experience in transferring bioprocesses to pilot plants or
manufacturing (cGMP) organizations and knowledge of data acquisition and
controls systems in these environments is a plus. Experience with statistical
experimental design and analysis of biological processes.
1. Works with team to direct,
investigate and optimize innovative vector production methodologies.
2. Coordinate with team of scientists
focused on developing and optimizing cell culture processes for recombinant
viral vectors for early- and late-phase clinical trials.
3. Implement and integrate strategies
into the work flows.
4. Design and execute mammalian cell
culture experiments with the goal of developing robust and scalable processes
for adeno-associated viral (AAV) vectors with appropriate product quality
attributes for clinical applications.
5. Demonstrate leadership and capability
to mentor junior colleagues, and fosters a team environment.
6. Troubleshoot scientific and technical
challenges, and contribute to their resolution.
7. Analyze and communicate experimental
results both orally and in written reports to colleagues and management.
8. Ensures effective, high-quality,
timely and appropriate documentation in laboratory notebooks and internal
9. Contribute to equipment procurement,
laboratory set up and organization.
10. Contributes to a safe, efficient and
effective lab environment with personal accountability.
11. Coordinate Process Development with
Manufacturing, Quality Assurance, and Project scientists.
**Other Duties: Performs other duties as
position is security-sensitive and subject to Texas Education Code 51.215,
which authorizes UT Southwestern to obtain criminal history record information
Medical Center is committed to an educational and working environment that
provides equal opportunity to all members of the University community. In
accordance with federal and state law, the University prohibits unlawful
discrimination, including harassment, on the basis of: race; color; religion;
national origin; sex; including sexual harassment; age; disability; genetic
information; citizenship status; and protected veteran status. In addition, it
is UT Southwestern policy to prohibit discrimination on the basis of
sexual orientation, gender identity, or gender expression.