Senior Scientist, Separation Sciences
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 a Senior Scientist to join our Separation Sciences group in the Analytical Development department. The qualified individual should have demonstrated proficiency with development and application of physico-chemical methods for phase-appropriate characterization of protein or vaccine products, including chromatography, capillary- and gel-based electrophoresis techniques, UV/Vis spectroscopy, particle analysis. The candidate will take a leading role in establishing strategy, development and validation of molecular biology and immunoassays for testing vaccine products. The candidate will be expected to work efficiently with cross-functional teams. Good understanding FDA and ICH guidelines and practical knowledge with assay validation is required for this position.
Responsibilities include but not limited to:
- Developing and validating chromatographic, electrophoretic, and biophysical methods for characterization of recombinant protein vaccine products
- Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product characterization
- Perform tech transfers to QC and other groups and external partners
- Thoroughly analyze results, solve analytical problems, and troubleshoot assays
- Prepare and review standard operating procedures (SOP), method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations
- Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology
- Present scientific findings at internal and external meetings
- Participate in cross-functional workflows and provide scientific guidance to teams
- PhD in analytical science, chemistry, biochemistry or related field with minimum of 5 years of experience in biopharmaceutical and/or vaccine development
- A thorough understanding of electrophoretic and chromatographic techniques in protein analysis is required
- Experience with gel electrophoresis, HPLC, CE, and optical spectroscopy is required
- Strong expertise in development of separation methods for recombinant proteins
- Ability to critically analyze data using statistical tools and to compile and review technical reports
- Demonstrated capability of working collaboratively and cross functionally
- Understanding of FDA regulatory requirements associated with analytics and characterization and documentation of vaccine products
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements
- Good understanding of statistical tools and knowledge of DOE and QbD principles is preferred
- Strong communication, presentation, and writing skills
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.