Scientist III Downstream Process Development
The Scientist III Downstream Process Development will contribute to Process Development within a project team to provide experimental design and planning and work in the development, evaluation, and characterization of downstream processes to produce novel therapeutic products. Collaborate between and act as a technical SME for associated departments and client representatives.
This position is in the Bryan-College Station area. The expectation is to be on site five business days a work or as required.
Identify, design, execute and analyze experimental protocols and present results to senior leadership, clients, and team members.
Authoring and revision of: SOPs, batch records, data presentations, study design and protocols.
To assess manufacturing processes supplied by client companies for suitability for GMP manufacture and identify any scale-up requirements/issues.
Assist in the technology transfer process to enable clinical manufacture, using novel processes, within the GMP environment. This may require direct involvement in clinical manufacture as an SME.
Operate and maintain a variety of lab equipment including but not limited to automated cell counters, bio-analyzers, microscopes, pumps, bioreactors, scales, tubing welders/sealers and pH/conductivity meters.
Serve as an SME for chromatography and TFF purification.
Maintain good communication across the team and to leadership
Bachelor’s degree minimum in a scientific discipline e.g., Biology, biochemistry, Virology, etc.
5+ years in a Process Development role with cGMP experience, in the biotech industry preferred.