Clinical-stage cell and gene therapy company
San Diego, CA
Process Development Engineer II
The Process Development Engineer II will focus on developing platform technology for the company's allogenic programs. This person will be working closely with the research teams as well as MSAT and manufacturing.
This position will be focused in the lab but also on the equipment side. Working with bioreactors and modeling the process using Six Sigma and implementing the technology in the lab.
- Bachelor's degree in a relevant, scientific field with 6 years of relevant process development experience OR Master's degree with at least 4 years of relevant process development experience
- Ideal candidate would come from cell therapy space but the hiring team would consider candidates out of biologics/monoclonal antibody background that have been involved in scale-up (up to 1000L for example).
- Experience with statistical modeling and DOE experience is also preferred.
- Solid knowledge of cGMP principals, ICH, FDA and EU guidance documents and quality systems
If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details. This is not a fully remote role.