• 21-May-2021 to 21-Jun-2021 (EST)
  • Upstream 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 Process Development Associate to join our Process Development Department in Gaithersburg, MD to expand our capabilities in technology transfer and process support of vaccine manufacturing processes. This position will have a wide range of responsibilities related to technology transfer, new technology evaluation and development, manufacturing technical support, viral clearance, and process validation of upstream, downstream and fill/finish processes. These activities support cGMP manufacturing operations for early and late-stage vaccine products. The position requires a collaborative person to work cross functionally with internal and external partners. The ideal candidate is creative and results-driven in order to advance science and improve business processes which elevate the quality and efficiency of our products and manufacturing processes.

Responsibilities include but are not limited to:

  • Tech Transfer and Scale up:
    • Prepare technology transfer documentation such as process descriptions, sampling plans and protocols. Perform facility fit evaluations to anticipate and solve manufacturing bottlenecks.
    • Provide process overview training to support implementation of new process technologies or significant changes to processes, equipment or manufacturing instructions.
    • Lead change control efforts for process changes and continuous improvement projects.
    • Plan and coordinate scale up and engineering runs for drug substance (e.g. cell culture and purification) and drug product manufacturing (e.g. fill/finish), evaluate scale up performance and recommend improvements to improve scalability.
  • Manufacturing Support:
    • Write and/or review Master Batch Records and Standard Operating Procedures for manufacturing operations. Generate continuous improvement ideas to improve documentation and business practices.
    • Support manufacturing by providing technical expertise in the manufacturing area and provide support for manufacturing investigations.
    • Compile, trend, and analyze manufacturing data from ongoing manufacturing campaigns. Author technical reports on the quality and performance of the campaign.
    • Identify and resolve complex technical problems in both manufacturing and process development. As appropriate, perform bench-scale experiments to support process development, generate robustness data, develop new technologies, and/or resolve manufacturing deviations.
  • Process Validation and Viral Clearance:
    • Design and coordinate process characterization studies utilizing multiple approaches including statistically designed experiments (DoE)
    • Design and coordinate small-scale process validation studies
    • Coordinate viral clearance studies at third party labs
    • Design at-scale process validation studies
  • Technology Development and Continuous Improvement:
    • Evaluate and implement new technologies that improve the quality, yield and efficiency of vaccine manufacturing processes and operations.
  • Other projects as assigned by management.

Minimum requirements:

  • Bachelors or master's in chemical engineering, biological sciences, biochemistry or related discipline.
  • B.S. and 5 years of experience or M.S. plus 3 years of experience in pharmaceutical, biologics, vaccines, or a related field.
  • Basic level understanding of biologics manufacturing is required in multiple areas including cell culture or fermentation operations, centrifugation techniques, preparative chromatography techniques, normal flow filtration and tangential flow filtration techniques with depth of knowledge in at least one area of upstream, downstream, or analytical techniques.
  • Ability to critically analyze data using statistical tools and to compile technical reports.
  • Knowledge and skill in statistical design of experiments is a plus.
  • A full understanding of current good manufacturing practices (cGMPs) as described in relevant federal code and regulatory guidance documents.
  • Some detailed understanding of FDA and EMEA regulatory requirements associated with process validation and viral clearance for biologic products.
  • Strong oral and written communication skills. Ability to influence cross-functionally in a matrix environment.
  • Proficient in Excel, PowerPoint, and Word applications.

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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