Overview:
The role is responsible for providing high-level support to the Research and Development (R&D) group. This includes supervising junior staff, leading technology transfer initiatives, overseeing GMP process and analytical method development, managing laboratory safety programs, and developing new assays or technologies as assigned. The position requires maintaining up-to-date knowledge of relevant theories and principles to effectively perform the duties. Responsibilities also include documenting experimental results, preparing publications as necessary, and training others on newly developed assays. Strong communication with the department and laboratory services personnel is essential. The role demands attention to detail, high-quality customer service skills, team leadership abilities, and the capability to instill these qualities in team members.
Responsibilities:
- Manage and coordinate research projects, early-stage new product and service development, and specialty projects, including clinical trial support and Investigational New Drug (IND) studies.
- Assist in managing the Center for Innovations and Biodesign within the R&D group.
- Conduct and supervise regenerative medicine-related research and development.
- Train and supervise junior staff, ensuring the implementation of relevant facility policies and procedures.
- Design and perform experiments for bioprocess development, optimization, and characterization.
- Conduct root cause analysis for unexpected results and provide alternative approaches or experimental strategies for problem-solving.
- Perform in vitro characterization of cell therapy products using protein and gene expression analysis.
- Design and execute experiments for individual bioprocess unit operations using relevant operational parameters.
Experience:
- For a Master's degree, three years of related industry post-graduation experience are required. For a Ph.D., one year of related industry post-graduation experience is required, along with one or more years of related academic experience.
- Hands-on experience with pluripotent stem cells, mesenchymal stem cells, T cells, or NK cell expansion using bioreactors.
- Prior experience in developing novel upstream processes for extracellular vesicles, recombinant proteins, antibodies, or early-stage viral vector manufacturing.
- Expertise in upstream processing techniques for mammalian cell expansion relevant to cell and gene therapy.
- Knowledge of bioreactors and process control, cell characterization methodologies such as cell counting, metabolic analysis, and the Design of Experiments (DoE) approach.