Scientist II, Downstream Process Development

TITLE:             Scientist II Downstream Process Development – Process Sciences

LOCATION:    Gaithersburg, MD

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. Our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic recombinant particles in order to address urgent global health needs.

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 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:

• 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 as needed basis

Minimum requirements:

• PhD in relevant scientific discipline with 0-3+ years of industry experience; may include post-doctoral experience
• MS in relevant scientific discipline with 3-5+ years of directly relevant experience
• BS in relevant scientific discipline with 7-10+ years of directly relevant experience
• Hands-on downstream purification experience is required
• Candidates that do not meet experience requirements may be considered for lower level positions

Useful qualifications for the role:

• 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.
• 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.
• Knowledge 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/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.

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