Novavax
  • 21-May-2021 to 21-Jun-2021 (EST)
  • Formulation Process 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 biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking a Senior Scientist, Formulation Development for the NanoFlu department, who can provide the following responsibilities and requirements below.

Responsibilities include but are not limited to:

  • Development of liquid formulations for VLP and nanoparticle based vaccines - through logical screening of excipients
  • Screening of suitable primary packing materials and delivery devices for vaccine product
  • Design and execution of accelerated stability testing for vaccine product
  • Analytical testing of formulation excipients, bulk formulations and final product
  • Experience with development of formulation screening tools and techniques that can predict stability
  • Supervise and coordinate Formulation Development activities within and outside the group
  • Supervise the activities of junior level scientists and development associates
  • Follow SOPs for routine assays (SDS-PAGE, Western Blot, Chromatography HPLC / GC, Particle sizing, ELISA, Protein assay, UV Spectroscopy etc.)
  • Working knowledge of protein analytical techniques CE, CD, FTIR, Fluorescence techniques, Calorimetry, Biacore
  • Documentation of results through writing, reviewing, and editing of standard operating procedures and reports
  • Maintenance of accurate records of all product development activities
  • Ability to analyze and determine the applicability of laboratory data to draw conclusions and to make appropriate recommendations
  • Knowledge of accelerated stability testing as per ICH guidelines

Minimum requirements:

  • PhD in relevant scientific discipline with 5+ years of industry experience; may include post-doctoral experience
  • Candidates without PhDs may sometimes be considered if they are top performers and have earned a Masters and have 10+ years of directly relevant experience, or have earned a Bachelors and have 13+ years of directly relevant experience
  • Knowledge and expertise in development and characterization of nanoparticle technologies
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
  • Knowledgeable in FDA / CBER regulations regarding the manufacturing of biological and/or vaccines
  • Proficient in Windows based software to include Excel, PowerPoint, Word
  • Working knowledge of DOE software i.e. JMP or similar
  • Demonstrated verbal and written skills in communicating technical and regulatory information
  • Experience in handling sterile dosage forms and aseptic preparation techniques
  • Experience in aseptic development of late stage clinical products and/or commercial products beneficial but not a must
  • Experience in development of adjuvanted vaccines beneficial but not a must

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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