Extensive hands-on experience with aseptic technique and mammalian cell culture for the purpose of generating clonally derived cell lines to produce monoclonal antibodies or vaccine candidates
Demonstrated ability to produce and screen hundreds of clonally derived CHO or 293 cell lines for top performers
Expertise in designing and constructing plasmids for gene expression using molecular cloning methods
Hands-on experience with multiple supporting technologies for cell line engineering, including cell counting, high-throughput transfection, single-cell cloning/deposition, flow cytometry, automated liquid handling systems, and automated small-scale bioreactor systems
Ability to independently design experiments and work plans and manage project timelines for multiple complex projects simultaneously
Experience preparing technical reports, SOPs, data presentations, and documents needed for technology transfer and regulatory filing
Expertise in molecular biology techniques for genetic characterization of cell lines, including RT-PCR and NGS
Plan and execute the generation of stable cell lines for preclinical and clinical material production to advance candidates including monoclonal antibodies, recombinant proteins, and virus like particles — 1
Use molecular biology techniques, including RT-PCR and NGS, for genetic characterization of cell lines — 2
Gene synthesis including oligo synthesis, plasmid design, and construction — 3
Independently execute all steps of the process including plasmid construction, stable pool generation, single cell cloning, and top clone selection
Supports the planning and execution of research experiments in the context of the laboratory's overall research program
Draft and verify data for CMC sections of pre-IND and IND documents to ensure successful registration of candidates
Design, perform, and troubleshoot experiments and analyze data for both development and deliverable projects
Supports laboratory staff on research projects and techniques
Maintain and support one or more pieces of laboratory instrumentation
Maintains laboratory equipment and the training of others in their use
Assists in maintaining adequate space and facilities for ongoing and projected research studies
Identify, propose, and execute process and procedural changes to improve performance, robustness, productivity, and efficiency by reviewing recent literature and new technologies
Evaluates, analyzes and interprets research data, communicates results and methods in reports, presentations, and manuscripts
Develop and track timelines and experimental plans for multiple projects simultaneously and regularly review records of tasks performed by other team members
Coordinates with junior staff to modify research protocols
Prepare oral presentations and posters for internal and external groups/conferences
Present results of clinical and experimental research at recognized scientific meetings by lectures and exhibits (poster sessions)
Presents research at national scientific meetings and symposia
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
Provides interpretation of results, guidance, and scientific support to the management team
Train staff on the proper usage of equipment
Mentors junior level scientists