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Senior Scientist, Downstream Process Development - NanoFlu New




Gaithersburg, United States

United States





Not specified

Permanent | Full Time

If you find science, speed, and success exhilarating, you have come to the right place.Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.We are seeking a Senior Scientist to join our Downstream Process Development Department - NanoFlu in Gaithersburg, MD. Qualified inpiduals will play a leading role on downstream process development; scale up, and technical support of cGMP manufacturing for proteins, nanoparticles and virus-like particle (VLP) based 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 Development.Responsibilities include but are not limited to:* Take a lead role in the assessment of a new purification process, by reviewing and compiling relevant literature data to include structure, physico-chemical, and biological data on the target protein, to propose the most suispan purification process train of steps based on these data.* Optimize the proposed process to demonstrate it is robust, high purity/yield, economic and scalable for clinical stage manufacturing of nanoparticle vaccine and other biologic product candidates, with particular attention to regulatory expectations on product quality and also on 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 communicate clearly and timely the implications of the results.* Perform and analyze Design of Experiment (DOE) studies to develop or optimizing processes to ensure a phase-appropriate, consistent, high-yielding, high-purity, and scalable downstream purification.* Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management.* Assist in scale up and optimization of early stage 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.* Responsible for integrating robust viral clearance steps into the process and working closely with the Viral Clearance Validation team, including review of protocols, execution of studies, and report writing.* This position is expected to be mainly hands on in the laboratory.Minimum requirements:* PhD in relevant scientific discipline with 5+ years of industry experience; may include post-doctoral experience* Candidates without PhDs may sometimes be considered if they are top performers and have earned a Masters and have 10+ years of directly relevant experience, or have earned a Bachelors and have 13+ years of directly relevant experience.* Solid and hands-on downstream purification experience is required. Multi-year industrial purification experience with vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus.* Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing and good organization skills are required.* Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.* 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.* Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.* Proficient in Window based software including Excel, PowerPoint and Word.Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.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/DisabledNovavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all inpiduals 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.

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