• 08-Jun-2021 to 07-Jul-2021 (EST)
  • Analytical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

We are seeking an experienced analytical scientist to join our Analytical Development Department. The qualified individual should have experience with immunoassays for testing process-related impurities (host cell proteins) quantitation using ELISA and other immunoassays. on sample testing and product characterization using electrophoretic technologies such as SDS-PAGE, Western Blot, Octet Biolayer Interferometry (BLI) and ELISA. Experience or knowledge on other analytical technology such as high-performance liquid chromatography (HPLC), total protein analysis including A280, and cell-based assay is a plus. The position requires initiation and involvement in the development and qualification/validation of assays, OOS investigations and troubleshooting, writing SOP, development report and qualification/validation report. The ideal candidate will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.

Responsibilities include but are not limited to:

  • Develop immunoassays for analysis and biological characterization of virus-like particle and protein nanoparticle vaccine products
  • 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
  • Maintain effective communication with process development, formulation, QC, discovery, and their testing needs
  • Perform method qualification/validation, and method transfer to other departments (e.g. QC)
  • Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays
  • Follow SOP to test in-process samples using SDS-PAGE densitometry, Western Blot, Octet BLI and ELISA to support process development and stability studies of nanoparticle vaccines.
  • Analyze gel image data using Image Lab and document in-process testing data.
  • Optimize and troubleshoot SDS-PAGE, Western Blot, Octet BLI and ELISA assays.
  • Involve in qualification and validation of in-process assays.
  • Present sample testing data at internal meetings

Minimum requirements:

  • BS or a MS with a degree in biology, chemistry, biochemistry or equivalent.
  • Minimum of 2-3 years' experience in pharmaceutical, biologics, and/or vaccine development.
  • Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
  • Understanding GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products.

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

Novavax offers a base salary, annual bonus, equity grants, 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 is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.


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