Senior BPD Scientist

1 month ago

Silver Spring, United States CAMRIS Full time

We are seeking a Senior Biologics Process Development (BPD) Scientist - Cell Line Development to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.

CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.


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.


Qualifications

  • 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.


CAMRIS International, LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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