Technical Requirements:

• Advance vaccine and therapeutic protein candidates including monoclonal antibodies, recombinant proteins, and virus-like particles by developing stable cell lines for preclinical development programs.

• Independently culture mammalian cells in plates, shake flasks, and small-scale bioreactors with aseptic technique.

• Perform transfection, selection, cloning, and maintenance of cells expressing proteins of interest.

• Generate stable pools and perform transient protein production for supply of reagent-grade material.

• Prepare plasmid DNA using standard molecular cloning techniques.

• Participate in cell line development platform design, optimization, and cycle-time reduction studies including methods for clone selection, expansion, ranking, and characterization by reviewing recent literature and new technologies.

• Identify, propose, and execute process and procedural changes to improve process performance, robustness, productivity, and efficiency.

• Independently design, perform, and troubleshoot experiments and analyze data.

• Plan and execute cell line development projects from plasmid construction through top clone selection .

• Oversee maintenance and support for one or more pieces of laboratory instrumentation.

• Generate, maintain and review accurate daily records of experiments and results in a laboratory notebook.

• Prepare and review experimental plans, proposals, reports, SOPs, and production records.

• Collect information, draft and verify data for CMC sections of pre-IND and IND documents to ensure successful registration of candidates.

• Review experiments in order to evaluate the progress of the research and ensure that experiments and documentation conform to established protocols.

• Work closely with other members of CLD team, upstream process development and downstream process development teams to improve workflow efficiency and overall process yield.

• Work with Federal Task Leader to manage project timelines and provide regular updates to project teams.

• Coordinate team meeting updates and presentations.

Specific Qualifications:

• Ph.D. in Biological Sciences with a minimum of 2 years of independent research experience in an academic or industrial setting.

• Hands-on experience with aseptic technique and mammalian cell culture

• Demonstrated ability to generate stable mammalian cell lines with experience expressing monoclonal antibodies or vaccine candidates

• Hands-on experience with supporting technologies for cell line engineering including cell counting, high-throughput transfection, single-cell cloning, flow cytometry, and automated small-scale bioreactor systems.

• Hands-on experience designing and constructing plasmids for gene expression using molecular cloning methods, PCR, and agarose gel electrophoresis as well as supporting software for generating and editing plasmid maps.

• Ability to independently design experiments and work plans and manage project timelines for complex projects.

• Experience in preparing technical reports, standard operating procedures, and data presentations.

• Ability to work in a collaborative environment within the cell line development team and with other teams.