02 Sep
Sr/Principal Engineer, Downstream Process Development
Vacancy expired!
Our client is a clinical-stage company focused in the immuno-oncology space. They are seeking a Sr/Principal Engineer, Downstream Process Development and Manufacturing to work hand-in-hand with the Head of Downstream Process Development in the development and manufacturing of both clinical-stage and pre-clinical products. Must have qualifications:
- 5+ years in industry
- Experience supporting internal or external technology transfers
Extensive hands-on experience with purification process development and/or manufacturing of biologics (AKTA, SEC, IEX, Mixed-mode, AEX, TFF, UF/DF, etc)
Strong written and communication skills
- Experience overseeing CDMO partners
- Experience in with JMP, Minitab, etc for DOE and statistical analysis
- Oversee process development and manufacturing activities within CDMO partners
- Meet with CDMO partners for PIP, troubleshooting, etc.
- Assist in the writing of IND and BLA filings
- Participate in validation, characterization, and DOE activities
Review and approve master batch records
Assist in technology transfers to and between CDMO partners
Vacancy expired!