Scientist, Analytical Development

Job Description
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.

The qualified individual should have experience with virological methods and enzymatic assays. Prior experience and knowledge with virus titration, immunodiffusion techniques, enzyme-based assays, and cell-based assays are required. Familiarity with other analytical techniques for biological analysis and characterization is a plus. The position requires initiation and involvement in the development and qualification/validation of assays, assistance in assay investigations and troubleshooting. The ideal candidate will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments. The candidate will work independently and collaborate with other team members and other groups.

Responsibilities include but are not limited to:

• Develop and qualify virological, enzymatic, and cell-based assays for product release, in-process testing and characterization of virus-like particle and protein nanoparticle vaccine products.
• Apply technologies for in-process testing and process validation.
• Support Discovery testing needs for the projects in the pipeline.
• Perform method qualification/validation, and method transfer to other departments (e.g. QC).
• 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 filings.
• Present scientific findings at internal meetings and external conferences.

Minimum Requirements:

• Master's or Ph.D. in biological science or biochemistry. Minimum of 8 years' experience for Master degree and 3 years for Ph.D. degree in pharmaceutical, biologics, and/or vaccine development.
• A thorough understanding of virus titration, immunodiffusion, enzymatic activity, DNA/RNA, and cell-based techniques in impurity and bioactivity analysis is required.
• Ability to critically analyze data using statistical tools and to compile technical reports.
• Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
• Ability to work effectively with cross-functional groups.
• Ability to prepare technical reports and presentations.
• Understanding of GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products.

Company

Novavax

Job Code

State or Province

Maryland

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