QC Senior Stability Specialist

Novavax Gaithersburg , MD 20877

Posted 2 weeks ago

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

We are expanding our internal Quality Control capabilities in support of our promising SARS-COV-2 Vaccine and we have a Senior Stability Specialist position that we are seeking to fill with a candidate that is ready to contribute to a growing team in support of this exciting and important program. The Senior Stability Specialist will be a member of the Quality Control Department reporting into the Senior Stability Manager, Quality Control. The QC Senior Stability Specialist will work collaboratively with internal and external teammates in Quality, Manufacturing, and Supply Chain to manage stability programs across several external partners while assisting with the establishment of internal stability capabilities/programs.

Job Overview:

The primary focus of the role will be to support all vaccine stability programs from clinical development through commercialization by providing quality oversight and management of cell banks, virus stocks, drug substance drug product intermediates, and drug products.

Primary Responsibilities include but are not limited to:

  • Execute day to day operations of the stability program through data compilation/analysis, and authoring/ review/ approval of protocols and reports

  • Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and on time

  • Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.

  • Responsible for generating, updating, and retiring stability-related SOPs, as appropriate.

  • Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and Novavax' internal SOPs.

  • Represent QC Stability on cross functional meetings/teams

  • Other duties as assigned.

Basic Qualifications:

  • Bachelor in a Life Sciences discipline or equivalent experience plus 8 or more years of relevant experience in a GxP environment with at least 3 years of Stability experience in a GMP regulated environment.

  • Scientific background in analytical methods and stability of Biologics

  • Experience in writing SOPs, investigations, stability protocols and reports as well as annual product performance reports.

  • Experience with LIMS, QMAS (or similar), and statistical software (.JMP) is preferred.

  • Experience interfacing with CMOs/CTLs

  • Possess excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines

  • Possess excellent customer service skills and have strong verbal and written communication skills

  • Strong attention to detail

  • Effective Problem Solving

  • Ability to work independently and carry out tasks with general instruction

  • Ability to work in a dynamic and fast paced team environment

  • Fundamental Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products

Preferred Qualifications:

  • Experience with QMAS and JMP
    • Experience working with external suppliers: CMOs/CROs/CTLs

Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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