Senior Biologics Process Development Scientist

4 weeks ago

Silver Spring, Maryland, United States CAMRIS International Full time
Job Summary

We are seeking a highly skilled Senior Biologics Process Development Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The ideal candidate will have expertise in developing clonal cell lines, including mammalian cells, and experience with cell line development for manufacturing processes involving bioreactors.

Key Responsibilities
  • Establish the engineering and development of novel cell lines as well as establishing clonal cell lines for the manufacturing of novel WRAIR vaccines and therapeutics.
  • Develop/implement high throughput analytical methods to apply in establishing and selecting clonal cell lines.
  • Implement high throughput cell line selection/characterization methods using Molecular Devices ClonePix, shake flasks, micro-bioreactors, as well as small-scale bioreactors.
  • Plan and execute experiments using established practices and technologies to construct product-specific clones from industry-standard mammalian host cell lines, evaluate clone performance, product quality, and productivity, and recommend a primary clone.
  • Make recommendations based on study results, scientific principles, and industry best practices on clone selection and process design.
  • Responsible for and/or support cell culture process development, technology transfer, and scale-up to support the early phase development of recombinant therapeutic proteins.
  • Support the review and approval of transfer and manufacturing documentation, such as batch records, standard operating procedures, sample plans, protocols, and summary reports.
  • Work independently on assigned tasks/projects, collaborate with other teams to improve processes, and communicate results to the relevant groups, including CMC teams.
  • Write and review standard operating procedures and technical reports.
  • Author process development and technology transfer documentation and relevant sections of regulatory filings, such as INDs and IMPDs.
  • Serve as a technical expert in cell sciences and provide hands-on technical leadership in designing, planning, executing, analyzing, and reporting cell line development and cell culture process development studies to advance WRAIR's biologics pipeline products.
  • Constructing and characterizing recombinant stable cell lines suitable for clinical supply of recombinant biotherapeutic proteins, covering vector design and engineering, stable cell line transfection, and screening along with the characterization of candidate production cell lines.
  • Perform transient and stable transfection of cell lines for spike ferritin nanoparticle vector production.
  • Responsible for the experiment execution, data review, and analysis; prepare presentations and project plans as needed for internal and external discussion.
  • Operate, maintain, and troubleshoot key technologies and instruments for cell culture and cell line development.
  • Responsible for cell line construction, clone selection/expansion, and clonal stability assessment, including hands-on as well as supervisory functions, as needed.
  • Supervise, train, and mentor Biologics Process Development (BPD) peers as needed and delegate/plan work within the team, as well as work hands-on with the team in the laboratory.
  • Perform transfection, selection, and single-cell cloning of mammalian cells.
  • Perform culture mammalian cells in plates, shake flasks, and small-scale bioreactors with aseptic technique.
  • Perform plasmid cloning by PCR, restriction digest, and bacterial culture.

Requirements
  • PhD in cell biology, molecular biology, biochemical/chemical engineering, biochemistry, or a related field and 8 years of experience (preferred), or an equivalent combination of credentials and experience.
  • Expertise in developing clonal cell lines, including mammalian cells.
  • In-depth experience generating stable cell lines using ClonPix or other clonal section equipment (e.g., Berkley Lights Beacon).
  • Experience with cell line development for manufacturing processes involving bioreactors.
  • Demonstrated proficiency in molecular cloning techniques.
  • Ability to multi-task and hit project timelines.
  • Excellent leadership and oral and written communication skills.
  • Must have eligibility to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.

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