Quality Control Analyst III - Novavax, Inc. - Gaithersburg, MD

Job detailsJob TypeFull-timeFull Job DescriptionIf 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 an Experienced Quality Control Analyst to join our Quality Control team in Gaithersburg, MD. Qualified individuals will be responsible for performing assay qualification and validation as well as analytical testing on in-process samples, drug substance and drug product for release and in support of stability studies. Responsibilities include but are not limited to: Performs GMP release and stability testing in Quality Control Analytical methods include: UV Spectroscopy, RP-HPLC, BCA, qRT-PCR, ELISA, SDS-PAGE, Capillary Electropheresis Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures Participates actively in technology transfer, method qualification and validation Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate Assists in the writing, reviewing and editing of standard operating procedures Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses Performs root cause investigation and analysis Participates in continuous improvement projects Assist in the maintenance of the lab including routine housekeeping activities Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development Other duties as assigned Minimum requirements: Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline Minimum of 5 years years of related experience working in a quality control laboratory environment Knowledge and expertise in principles and practices of current Good Manufacturing Practices (GMPs) Excellent analytical skills and knowledge Strong troubleshooting skills for equipment and software Excellent communication/interpersonal and presentation skills Experienced with EHS guidelines in a laboratory environment 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. #LI-KC1

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