Novavax, Inc. (NASDAQ: NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax has a late stage quadrivalent influenza nanoparticle vaccine (NanoFlu), to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. ResVax, an RSV vaccine for protection of very young infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is designed to prevent severe lower respiratory tract infection which is the second leading cause of death in children under one year of age worldwide. Novavax has also developed early stage products for emerging diseases based on its proprietary nanoparticle technology as well as it's Matrix adjuvant, currently in testing across all age demographics.
We are currently preparing for process validation and licensure of a late phase seasonal influenza vaccine and beginning phase I clinical work for a vaccine against the SARS-nCoV-2 novel Coronavirus. To assist with these programs, we are seeking a Manufacturing, Sciences, and Technology Engineer who is responsible for technical oversight of external development and manufacturing activities for vaccine drug substances (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Responsibilities include, but are not limited to:
Partnering with Contract Development and Manufacturing Organizations (CDMOs) to oversee drug substance development and manufacturing activities
Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages
Preparing, reviewing, or approving process flow diagrams, development reports, and master batch records
Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
Assisting with the writing and reviewing documents for INDs / regulatory section submissions
Prepare, review, or edit validation, CMC regulatory, and Quality documents
Collaboration with other CMC team members to build and execute the CMC development plan
Trending of drug substance process data, identification and investigation of adverse trends
Partnering with CDMO representatives to investigate process and analytical deviations
Working closely with project managers at both Novavax and CDMO's to ensure project milestones are maintained
MS or BS in engineering, chemistry, biology, or related discipline, plus at least 2 years of experience in vaccine or biologic manufacturing operations
Proven experience in collaborating in matrix teams in a technical environment
Strong project management skills and adept at working collaboratively with cross functional teams
Strong interpersonal and communication skills
Knowledge of protein production and purification manufacturing technologies, such as:
Shake flasks and stirred tank bioreactors
Clarification by depth and tangential flow filtration
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in 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.