The Senior Research Associate is a key member of the growing Pharmaceutical Sciences and Technology team and is responsible for executing cell culture development activities in our laboratory and contributing to projects with our partner organizations.
Reporting to the Senior Process Scientist (the leader of the cell culture team), the Senior Research Associate role will execute cell line development workflows and cell culture development experiments in our laboratory. The Senior Research Associate will also contribute to contracted activities at Contract Development and Manufacturing Organizations (CDMOs). The individual will work closely with internal partners in Quality Assurance, Research, and Regulatory as well as with external partners.
Responsibilities
- Conducting shake flask and bioreactor operations for small scale development and characterization of cell culture processes for Visterra's antibody products.
- Conducting cell line development activities in line with regulatory guidance to establish Research Cell Banks for use in GMP Master Cell Bank generation.
- Assist with developing producer cell lines from DNA construct assembly through genetic stability testing.
- Independently prepare DNA vectors using standard molecular biology techniques including homology-based cloning, transformation and propagation in bacteria, and kit-based purification.
- Independently execute work to develop cell culture platform processes to support in-house material generation to support research and pre-clinical studies.
- Independently operating laboratory cell culture equipment including bench-scale bioreactors, shake flasks, and multiwell plates.
- Monitoring and sampling of cell culture processes daily; including testing for attributes such as cell viability and density, metabolites, pH, and more.
- Contribute to cell culture technology transfer activities including:
- reviewing and presenting process data
- troubleshooting results of small scale and pilot scale data
- performing scaleup calculations
- Support GMP manufacturing through review of Batch Records and support for deviation investigations
- Support GMP manufacturing as a Person-in-Plant representing Visterra at CDMO sites.
- Presenting work at department and cross functional meetings and presenting relevant updates on lab activities at drug development team meetings.
- Troubleshooting and maintaining laboratory equipment.
- Documenting experimental results in lab notebooks, tech transfer documents, and technical reports and presenting data at meetings.
- Keeping current with new technologies to improve process development capabilities.
- Traveling up to 10% of the time for site visits at CDMOs and to attend conferences
Requirements
- B.S. in Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or Biological Engineering (or related disciplines) with 3 years of relevant industry experience, or M.S. with 1 years of relevant industry experience
- Experience in maintaining and troubleshooting mammalian cell culture operations.
- A strong understanding of cell culture parameters in general (cell growth rate, cell density, viability, population doubling, metabolites and cell waste, etc.).
- Hands-on experience with aseptic techniques for mammalian cell culture operations.
- Experience with transfection of mammalian cells for transient and/or stable expression of genes of interest.
- The ability to think critically and communicate effectively across broad spectrum of audiences both internal and external.
- An ability to work independently, meet deadlines and prioritize work effectively.
- The ability to travel to conferences and global manufacturing sites up to 10% of the time.
- Due to the nature of cell culture activities, some work outside of non-standard hours, including weekend work is required.
