Novavax
  • 08-Sep-2017 to 07-Nov-2017 (EST)
  • Analytical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.

We are seeking a Scientist I to join our Analytical Development Department in Gaithersburg, MD. The qualified individual should have extensive experience with ELISA-based immunoassays. The position requires initiation and involvement in the development and qualification/validation of quantitative immunoassays for vaccine products and process-related impurities (host cell proteins). The ideal candidate will make detailed observations, analyze data, interpret results, write qualification/validation reports and SOPs, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.  The candidate will receive general instructions from a supervisor and will work independently, as well as collaborate with other team members and other groups.

 

Responsibilities include but are not limited to: 

  • Develop immunoassays (ELISA) and label-free binding assays (SPR) for analysis and biological characterization of virus-like particle and protein nanoparticle vaccine products and process-related impurities (host cell proteins)
  • Responsible for preparation and characterization of host cell protein (HCP) standards and specific antibodies
  • Responsible for determination of process-related impurities.
  • Perform characterization studies to understand potential impact of impurities on safety and immunogenicity.
  • Apply new cutting-edge technologies for in-process testing and product biological characterization. Experience with Surface Plasmon Resonance (SPR) is highly desired
  • Support Discovery testing needs for the projects in the pipeline
  • Perform method qualification/validation, and method transfer to other departments (e.g. QC)
  • Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays
  • Maintain effective communication with process development, formulation, QC, discovery, and clinical groups
  • Write, review, and edit of standard operating procedures and qualification/validation reports
  • Prepare technical reports and scientific journal publications and presentations. Provide selected sections for CMC regulatory filing
  • Present scientific findings at internal meetings and external conferences
  • Preparation and characterization of critical reagents and data trending

 

Minimum Requirements: 

  • Master's or Ph.D. in biological science or related field. Minimum of 5 years' experience for Master degree and a minimum of 2 years for Ph.D. degree in pharmaceutical, biologics, and/or related field
  • A thorough understanding of immunoassay, enzyme assays, and label-free binding techniques in protein analysis is required
  • Ability to critically analyze data using statistical tools
  • Proficient in Microsoft Excel and/or other statistical tools to critically analyze data
  • Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements
  • Ability to work effectively with cross-functional groups
  • Ability to prepare technical reports and presentations
  • Understanding of GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products

 

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Novavax
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