| Job Description | Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a 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 ELISA, label-free binding assays (SPR) and enzymatic assays for testing bioactivity of proteins or vaccine products. The position is responsible for development, qualification and validation of potency assays using ELISA, SPR and enzymatic assays. The ideal candidate will make detailed observations, analyze data, interpret results, write qualification and validation reports and SOPs, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.
Responsibilities include but are not limited to:
• Develop immunoassays and enzyme assays for analysis and biological characterization of virus-like particle and protein nanoparticle vaccine products
• Responsible for determination of biological activity in vaccine products.
• Apply new cutting-edge technologies for in-process testing and product biological characterization
• Support testing needs for the projects in pre-clinical 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 and qualification/validation reports
• 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 PhD in biological science or biochemistry. Minimum of 1-5 years' experience in pharmaceutical, biologics, and/or vaccine development.
• A thorough understanding of immunoassays, label-free binding assays and enzyme assays in protein 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 GMP requirements and other FDA regulatory requirements associated with analytical testing 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. |
| | Company | | Novavax | Job Code | | State or Province | | Maryland | | |
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