Scientist III Downstream Process Development

P1053

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.