Sr. Associate Scientist/Scientist, Analytical Development
Novavax - Maryland

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Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field.

We are seeking a Sr. Associate Scientist/Scientist to join our Analytical Development department in Rockville, MD. The qualified individual will be responsible for physicochemical analysis and characterization of vaccine products. The candidate will apply state-of-art characterization techniques, such as mass spectrometry and chromatography, for structural characterization in order to build in-depth product understanding. Familiarity with biophysical techniques for higher order structure, particle analysis is a plus. The candidate will support Process Development and Discovery group needs. The applicant will prepare SOPs, technical reports, qualification reports, and contribute to CMC regulatory filings. The successful candidate will be expected to make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments in an independent manner.

Responsibilities include but are not limited to:

Develop and qualify physicochemical characterization methods for virus-like particle and protein nanoparticle vaccine products.
Responsible for mass spectrometry and chromatography techniques to characterize product variants and process-related impurities of vaccine products.
Build understanding of product heterogeneity related to primary and higher order structure, aggregation, fragmentation, and post-translational modifications including glycosylation.
Study relationship of structure and function of vaccine products to understand potential impact of product variants on safety and immunogenicity
Develop new cutting-edge technologies for in-process testing and characterization
Support Discovery testing needs for the projects in the pipeline
Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays
Maintain effective communication with process development, formulation, QC, discovery, and clinical groups
Write, review, and edit of standard operating procedures
Prepare technical reports and scientific journal publications and presentations. Provide selected sections for CMC regulatory filing
Present scientific findings at internal meetings and external conferences

Minimum requirements:

Masters or Ph.D. in biological science or biochemistry. Minimum of 1-5 years' experience in pharmaceutical, biologics, and/or vaccine development.
Strong expertise in physicochemical method development and structural characterization of vaccine products.
Experience in the mass spectrometry and HPLC analysis is a must.
Ability to work effectively with cross-functional groups.
Ability to prepare technical reports and presentations.
Understanding of FDA regulatory requirements associated with analytical characterization of vaccine products.

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.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

Novavax - 19 months ago - save job - block
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