Job Description:

- Be responsible of designing, planning, and executing experiments in upstream process development
- Develop and manage project plans and timelines. Be accountable for the timely preparation of progress reports and presentations according to agreed plans, milestones, and company guidelines for areas under direct responsibility
- Design, coordinate and conduct experiments toward cell culture process development, including media screening, feeding strategies optimization and cell culture in plates, shake flasks and bioreactors
Independently operate laboratory scale bioreactors and other cell culture vessels
- Troubleshoot and maintain laboratory equipment and instrument associated with the upstream process
- Author the process development, qualification or validation reports and lead the process transfer to production facility
- Closely collaborate with other cross-functional teams to provide support in cell line development, downstream process development, formulation development and animal studies
- Effectively and independently solve problems that arise within job responsibilities by evaluating data and information from multiple sources to determine root causes and generate innovative solutions to problems
- Function as the subject expert in the responsible area and provide support, coaching, or assistance to other team members

Qualifications

- Master degree with 2-5 years of cell culture process development experiences in biotech industry
- Significant experience in the areas of cell culture process development, scale up of bioreactors and GMP manufacturing, process characterization, tech transfer, process validation and BLA-enabling activities
- Experience in preparing and defending regulatory documents (BLAs/INDS)
- Knowledge of cGMP regulations
- Self-motivated, assertive, and self-confident with the ability to act with urgency and passion