Demo

Scientist

Course
San Antonio, TX Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

The individual in this position will be responsible for supporting and leading various aspects of research, technology transfer, GMP (Good Manufacturing Practice) processes, and analytical method development. They will also be tasked with supervising junior staff, managing laboratory safety programs, developing new assays or technologies, and contributing to various research projects.

Key Responsibilities :

  • Research & Development : Oversee and conduct R&D projects, including bioprocess development, cell therapy research, and supporting clinical trials and IND studies.
  • Training & Leadership : Supervise junior staff, implement policies and procedures, and train others on new assays or technologies.
  • Technology Transfer & Process Development : Lead technology transfer efforts and assist in the development of new bioprocesses, gene therapies, and cell manufacturing platforms.
  • Problem Solving : Investigate unexpected results and provide new experimental strategies to solve issues.
  • Cross-functional Collaboration : Work with teams across multiple departments to enable progress in clinical trials and regulatory workstreams (e.g., Phase I / II and BLA enabling).
  • Experimental Design & Execution : Design and perform experiments for bioprocessing, product characterization, and bioreactor-based cell culture processes for gene therapy vectors.
  • Reporting & Communication : Regularly report progress, present results at group meetings, and contribute to drafting protocols, method development reports, and publications.

Skills and Expertise Required :

  • Research Skills : Hands-on experience with pluripotent stem cells, mesenchymal stem cells, T cells, NK cells, and cell culture in bioreactors.
  • Process Knowledge : Familiarity with upstream processing techniques, process parameter optimization, and cell characterization methodology.
  • Bioreactor Experience : Experience with operating stirred-tank bioreactors, both for microbial and mammalian cell cultures.
  • Regulatory Knowledge : Knowledge of cGMP (current Good Manufacturing Practice) and Quality Management Systems (QMS).
  • Software Proficiency : Experience with data analysis tools like FlowJo and GraphPad.
  • Design Expertise : Experience with Design of Experiments (DoE) and Quality by Design (QbD) approaches for maximizing capacity and reducing production costs.
  • Educational Requirements :

  • Master's Degree : A thesis-based Master's in bioengineering, biotechnology, bioprocessing, or chemical engineering is required, along with 3 years of relevant industry experience.
  • Ph.D. (Preferred) : A Doctoral degree in a relevant field with at least 1 year of industry experience.
  • Industry Experience : Hands-on experience with stem cell expansion and early-stage manufacturing for cell and gene therapies is required.
  • Preferred Experience :

  • Expertise in cellular therapy product development, experience with stirred-tank bioreactors, and familiarity with GMP principles.
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