Plan experiments and conduct hands-on laboratory bench work to execute, optimize, troubleshoot, and scale up downstream processes for viral vectors and biologics.
Perform independent data recording, analysis and troubleshooting.
Support generation of SOPs, raw material specifications, batch records and reports, and provide project updates to customers in written and oral presentations.
Maintain expertise in gene therapy or biologics-related downstream processes and equipment and utilize it in the resolution of complex technical or operational problems.
Lead and execute process tech transfer activities while ensuring quality, and timeliness of deliverables are maintained.
Qualifications
Bachelor’s degree or higher in chemical engineering, molecular biology, biochemistry, or related discipline.
6+ years of relevant experience in a process development and/or pilot laboratory setting.
Experience with downstream purification of biological molecules required, with an in-depth knowledge of depth filtration clarification, chromatography, tangential flow filtration, and sterile filtration
Experience and knowledge in the design, modification and optimization of gene therapy or biologics downstream process parameters.
Ability to work in a Biosafety Level 2, follow safe lab procedures and maintain good laboratory practice (GLP).
