• 17-May-2021 to 16-Jun-2021 (EST)
  • Quality Assurance
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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. NanoFlu, 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 nanoparticles 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 Quality Operations Drug Substance Lead to join our Quality Assurance department in Gaithersburg, MD. The Quality Operations Drug Substance Lead will serve as the leader and operational manager to direct, oversee, and manage all quality assurance operations activities for Novavax, Inc as it relates to Drug Substance CMO Quality Oversight. Responsibilities include GMP/PAI CMO Inspection Readiness Management, ensuring oversight of batch manufacturing, CMO and Novavax process/documentation/facility related change management execution and issue management, Drug Substance release for CMO produced materials and quality review/approval of documentation related to CMO produced materials.

This position reports directly to the Senior Director, Quality Operations.

Responsibilities include but are not limited to:

  • Quality leader to set and execute QA Operations goals and objectives with Novavax Development, Manufacturing, Quality Control, and Supply Chain as well as Drug Substance CMO to ensure Working Virus Stock (WVS), Working Cell Banks (WCB), and Drug Substance (DS) is developed, manufactured, tested, labeled, and shipped to meet domestic and international regulations including but not limited to FDA and EU GMPs. This includes interface with internal and external Qualified Persons (QPs), internal Novavax supply nodes and CMOs/Contract Test Labs for manufacturing and testing of WVS, WCB and DS.
  • Supporting CMO GMP/PAI Inspection Management and readiness activities as well as leading the Novavax support team for WVS, WBC and DS CMO Inspections.
  • Supporting global quality operational strategies by establishing critical quality and operational metrics and measurements and conducting trend analysis for Drug Substance CMO activities.
  • Provides mentorship, leadership, and prioritization to staff to execute their respective duties.
  • Builds and promotes a culture of Operational Excellence within QA.
  • Stays current and is an internal Novavax subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
  • Effectively collaborates with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.
  • Supports regulatory inspections as necessary, including authoring and review of regulatory submissions as it pertains to QA.

Minimum requirements:

  • Bachelor's Degree in Biology, Chemistry, Engineering, or related field with 12+ years' experience in the Pharmaceutical/Biotech industry with 5+ years management experience.
  • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including technology transfer and PPQ.
  • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including experience hosting regulatory inspections.
  • Excellent multi-tasking, analytical, organizational and leadership skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.

Additionally, we prefer candidates that have:

  • The ability to effectively build and maintain relationships across the organization in order to effectively solve problems.
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
  • The ability to enable and drive change while being focused on internal and external customers.
  • Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.
  • Capable to manage multiple priorities and maintain adherence to timelines.
  • Experience in validation (process, test methods, cleaning, equipment, and utilities).

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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