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    MS&T Engineer - Downstream

    Gaithersburg, MD 20877
    Full-time, Part-time
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    Job Description

    Job Description

    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 currently seeking a Manufacturing Sciences and Technology Engineer with 3-5 years of experience in downstream processing, preferably in an MS&T/Tech Ops type role. This person will be responsible for providing technical support and expertise to SARS-CoV-2 commercial Drug Substance sites, leading technical investigations, data trending and analysis of manufacturing data, and preparation of documentation to support regulatory filings and other CMC documentation.

    Responsibilities include, but are not limited to:

    • Trending of drug substance process data, identification and investigation of adverse trends
    • Partnering with CDMO representatives to investigate process and analytical deviations
    • Assisting with the writing and reviewing documents for INDs / regulatory section submissions
    • Prepare, review, or edit validation, CMC, Regulatory, and Quality documents such as risk assessments and E&L, microbial control, viral control, and process control strategy documents
    • Working closely with project managers at both Novavax and CDMO's to ensure project milestones are maintained

    Minimum Requirements:

    • MS or BS in engineering, chemistry, biology, or related discipline, plus at least 3 years of experience in vaccine or biologic manufacturing operations
    • Proven experience in collaborating in matrix teams in a technical environment
    • Strong project management skills and adept at working collaboratively with cross functional teams
    • Strong interpersonal and communication skills
    • Knowledge of protein production and purification manufacturing technologies, such as:
      • Clarification by depth and tangential flow filtration
      • Column chromatography

    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.

    Job Posted by ApplicantPro

    Posting ID: 598159579Posted: 2021-01-24