Cell Line Development Scientist – Preclinical & IND Readiness

Axle Labs; Gaithersburg (MD); On-site; USD 120,000 - 127,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

Paid time off

401K match

Educational benefits

Employee referral bonus

Healthcare FSA

Parking reimbursement

Dependent care assistant program

Transportation reimbursement

Job summary

Axle is seeking a Scientist in the Cell Line Development Group to join our team at NIH/NIAID in Gaithersburg, MD. The role focuses on developing stable cell lines for vaccine and biotherapeutic candidates using advanced molecular and cell culture techniques.

The successful candidate will design and execute cloning, cell line generation, genome characterization, and regulatory-ready data packages while collaborating with cross-functional teams. Extensive hands-on experience is required.

Qualifications

• Master's or Ph.D. in Biological Sciences or 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.
• Proven ability to generate 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 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 manage project timelines for multiple complex projects.
• 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.

Responsibilities

• 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

Skills

Aseptic technique

Mammalian cell culture

Cloning & plasmid design

Molecular biology techniques

RT-PCR

NGS

Experimental design & project mgmt

Education

Master's or PhD in Biological Sciences

Tools

MS Office Suite

Job description

Axle is seeking a Scientist in the Cell Line Development Group to join our team at NIH/NIAID in Gaithersburg, MD. The role focuses on developing stable cell lines for vaccine and biotherapeutic candidates using advanced molecular and cell culture techniques.

The successful candidate will design and execute cloning, cell line generation, genome characterization, and regulatory-ready data packages while collaborating with cross-functional teams. Extensive hands-on experience is required.