Quality Control Analyst I/Ii

Novavax Gaithersburg , MD 20877

Posted 2 months ago

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.

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 ELISA, Rapid Titer, Cell Culture and SRID (Immunodiffusion assay).

  • Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses

  • 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

  • Performs root cause investigation and analysis

  • Assist in the maintenance of the lab including routine housekeeping activities

  • Other duties as assigned

Minimum requirements:

  • Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline

  • Minimum 1-3 years of related experience working in a biological quality control laboratory environment

  • Knowledge and expertise in principles and practices of current Good Manufacturing Practices (GMPs)

  • Analytical and troubleshooting skills pertaining to HPLC and previous experience with Agilent LC instruments will be preferred.

  • Excellent communication/interpersonal and presentation skills

  • Experienced with EHS guidelines in a laboratory environment

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


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Quality Control Analyst I/Ii

Novavax