Novavax, Inc

We are seeking a Scientist to join our Downstream Process Development Department - Process Sciences in Gaithersburg, MD. Qualified individuals will play a role in downstream process development; scale up, new technologies, and technical support of cGMP manufacturing for protein particle vaccines.. The candidate will ensure scientifically sound design and scalable purification processes are created.. Perform and analyze Design of Experiment (DOE) studies to develop or optimize downstream processes to ensure a phase-appropriate, consistent, high-yield, high-purity process.. Collaborate and coordinate with colleagues from Discovery, Process Development, Analytical Development, Manufacturing, and QA/QC teams.. Knowledge in purification of vaccines/biologics; Experience in various chromatography methods, filtration, and TFF unit operations at bench scale and pilot scale desired.

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If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide. Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
We are seeking a Scientist to join our Downstream Process Development Department - Process Sciences in Gaithersburg, MD. Qualified individuals will play a role in downstream process development; scale up, new technologies, and technical support of cGMP manufacturing for protein particle vaccines. The candidate will ensure scientifically sound design and scalable purification processes are created. The candidate will also be responsible for generating materials for pre-clinical studies and other development purposes. The candidate is expected to be highly self-motivated, well organized and very productive.
This position will be located at our Gaithersburg, MD facility and will report to the Manager of Downstream Process Sciences.
Responsibilities include but are not limited to:
Support the development of a new purification process by reviewing and compiling relevant literature data. Support and deliver materials for development, pre-clinical, and clinical studies. Optimize the proposed process to demonstrate it is robust, high purity/yield, economic and scalable for clinical stage manufacturing with particular attention to regulatory expectations on product quality, suitability, and sourcing of raw materials, reagents, and separation materials. Ensure unit operations are feasible to implement at the intended manufacturing scale. Design experimental work independently or with minimal supervision. Ability to process complex data and clearly communicate the implications of the results. Perform and analyze Design of Experiment (DOE) studies to develop or optimize downstream processes to ensure a phase-appropriate, consistent, high-yield, high-purity process. Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide assessment reports. Assist in scale up and optimization of downstream processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies. Provide reagents and other supplies for various projects and departments. Collaborate and coordinate with colleagues from Discovery, Process Development, Analytical Development, Manufacturing, and QA/QC teams. Support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing. This position is expected to have hands on laboratory and scale up operation in a routine basis. Minimum requirements:
PhD in relevant scientific discipline with 0-1+ years of industry experience; may include post-doctoral experience OR MS in relevant scientific discipline with 3+ years of directly relevant experience OR BS in relevant scientific discipline with 6+ years of directly relevant experience Hands-on downstream purification experience is required Strongly Preferred:
Knowledge in purification of vaccines/biologics; Experience in various chromatography methods, filtration, and TFF unit operations at bench scale and pilot scale desired. Direct experience with virus-derived recombinant products and/or viral particles is a plus. Expertise and knowledge in analytical methods such as SDS-PAGE, Western Blot, HPLC is preferred. Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing, and good organization skills are required. Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements. Demonstrated verbal and written skills in communicating scientific and technical information. Proficient in Window based software including Excel, PowerPoint and Word. Novavax offers a base salary, annual bonus, equity grants, 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 is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption. #J-18808-Ljbffr

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