Scientist II, Upstream Process Development

Gaithersburg, Maryland, United States
06 Dec 2023
21 Dec 2023
R & D , Scientific
Full Time
Experienced (non-manager)
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 Upstream Process Development Department - NanoFlu in Gaithersburg, MD. Qualified individuals will play a leading role on upstream 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 upstream processes are developed, optimized, and characterized. 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 and well organized. This position will be located at our Gaithersburg, MD facility and will report to the Manager of Upstream Process Development.

This position is expected to be hands-on in the laboratory and pilot scale-up facility with periodic weekend and late-shift work required focused on upstream process development, characterization, and scale-up.

Responsibilities include but are not limited to:
  • Develop robust, high-producing, scalable and economically viable cell culture production processes up to large-scale bioreactors
  • Develop, optimize and scale-up fed-batch bioreactor processes. Lead efforts to evaluate different cell culture media and feed formulations. Evaluate optimal feeding strategies to improve product yield, quality and purity
  • Complete process robustness and characterization studies for tech transfer to our manufacturing plants
  • Experience in developing kinetic and scale-down models to support process optimization, characterization and identification of appropriate scaling factors preferred
  • As needed, support process validation, including validation protocol writing, execution and report writing
  • Perform and analyze Design of Experiment (DOE) studies to fully characterize processes. Support process validation studies and activities. Participate in the technology transfer of processes to Manufacturing and external collaborators and partners
  • Perform critical operations as needed in our development and cGMP manufacturing facilities to deliver pre-clinical and clinical materials.
  • Support the build-up of our pilot scale-up facility for upstream operations to generate material for downstream
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management
  • Present experimental results to team members and across functional groups

Minimum Requirements:
  • PhD with 2 - 5 years directly related industry experience, MS with 6 - 8 years directly related industry experience or BS with more than 10 years of directly related industry experience
  • Experience with developing fed-batch bioreactor processes including optimizing feeding strategies and evaluating different cell culture media and feed formulations
  • Experienced in process optimization, scale-up and technology transfer
  • Extensive experience with small-scale and large-scale cell culture bioreactor process development is required. Experience with insect and/or mammalian is preferred
  • Hands-on experience in the operation of single use bioreactor up to pilot scale and supporting tech transfer to manufacturing plants
  • Demonstrated hands-on experience in process development including use of statistical design of experiments is required
  • Working knowledge of Cell Clarification/Harvest and Downstream purification is a plus
  • Demonstrated verbal and written skills in communicating complex technical information
  • Ability to critically analyze data using statistical tools and to compile technical reports.
  • Excellent record keeping abilities to adequately record, analyze and document development data generated in support of regulatory requirements
  • Experience with JMP or other similar software, a plus
  • Knowledge of process characterization and process validation of biological products
  • Practical experience with single-use disposable equipment applications for all typical unit operations used in biomanufacturing
  • Direct experience with virus-derived recombinant products and/or viral particles in a GMP environment is a plus
  • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
  • Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace and dynamic team setting

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)