Certifications & Licenses

• Master's or Ph.D. in Biological Sciences or a related field with a minimum of 2 years of experience in an industrial setting focused on the development of stable cell lines for vaccine and biotherapeutic candidates

   

Field of Study

• Biology

   

Software

• MS Office Suite

   

Skills

• 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

   

Deliverables

• Inspect Equipment — Ad-Hoc

• Meet with lab members to present updates — Ad-Hoc

   

Statement of Work Details

• 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