Quality Control Senior Analyst (NanoFlu)

    Updated 30+ days ago
    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 biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavaxis 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.Novavaxis 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 Quality Control Senior Analyst, who is responsible for day to day operations related to release and stability testing, writing SOPs, deviations, change controls and CAPAs as part of typical QC operations. In addition, the incumbent will perform testing of process development samples, as needed, to support non-GMP activities.

    This position will be located at our Gaithersburg, MD facility.

    Responsibilities include but are not limited to:

    • Performs GMP release and stability testing in Quality Control
    • Performs non-GMP sample testing to support Analytical Development and Process Development, such as SRID, SDS-PAGE, VaxArray, or other methods, as needed
    • Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses.
    • Review of laboratory notebooks, protocols and reports.
    • Participate in technology transfer, method qualification and validation
    • Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines
    • Participate in internal assessments and regulatory audits as required
    • Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
    • Leading the lab in 5S and routine housekeeping activities
    • Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing, Process Development and Analytical Development
    • Other duties as assigned

    Minimum requirements:

    • Minimum of a Bachelor's degree or equivalent in a scientific discipline
    • Minimum 5 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations
    • Previous experience with the SRID assay is preferred
    • Previous experience with immunoassays (ELISA, VaxArray, Luminex), physicochemical (SDS-PAGE, BCA, A280) or compendial methods (pH, Appearance, Osmolality) is a plus
    • GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required
    • Excellent analytical skills and knowledge
    • Strong troubleshooting skills for equipment and software
    • Solid ability to work independently (minimum supervision)
    • Ability to lead others, as needed
    • Ability to effectively collaborate with others
    • Excellent communications skills and be conversant in computer systems
    • Excellent multi-tasking and organizational skills.
    • Excels in time management
    • Strong attention to detail
    • Job holder should be a good understanding of relevant regulatory/industry standards and requirements

    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: 611747993Posted: 2021-03-21Job Title: Senior Analyst