- 09-Oct-2012 to 05-Jun-2013 (EST)
- Process Development
- Rockville, MD, USA
- Full Time
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 Senior Manager to join our Analytical Development department in Rockville, MD. Qualified individual will be responsible for leading a team of scientists for physicochemical analysis and characterization of vaccine products. The candidate will take a leading role in the development and qualification of a wide variety of assays as well as identification and evaluation of new technologies. The candidate will support process development and research group needs, and release and stability testing of clinical materials. The applicant will review 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 methods for virus-like particle and protein nanoparticle vaccine products.
• Responsible for chromatography, mass spectrometry, electrophoresis, biophysical tools to perform structural characterization and comparability testing of vaccine products
• Study structure and function relationship of vaccine products.
• Perform comparability assessment to support process changes
• Develop new cutting-edge technologies for improving efficiency of in-process testing and characterization.
• Support research testing needs for the projects in the research pipeline.
• Perform tech transfer to other groups and external partners.
• Ability to thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics.
• Maintain effective communication with process development, formulation, QC, research, and clinical groups.
• Writing, reviewing, and editing of standard operating procedures
• Prepare and review method development reports, protocols and reports, CMC regulatory filings, and scientific journal publications and presentations.
• Ph.D. in Chemistry or biological science with at least 8 years experience in pharmaceutical, biologics, and/or vaccine product development
• Strong expertise in physicochemical method development and structural characterization of vaccine products.
• Ability to manage a team of scientists, and develop and motivate scientists to achieve results
• Ability to define priorities and process to get things done.
• Ability to work effectively with cross-functional groups. Experienced in analytical tech transfer.
• Ability to critically review data and technical reports.
• Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs).
• Present scientific findings at internal and external meetings
• Other knowledge and competence:
o Strong people management experience, including leading staff at the various levels
o Experience in leading managing a laboratory
o Demonstrated teamwork, organizational, and leadership skills
o Proven ability to influence across functions and organizations
o Knowledge of DOE and QbD a plus
• Other duties as assigned
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.
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