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Quality Engineering Specialist IV Full-time

at Novavax Maryland in Maryland (Published at 18-10-2022)

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

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 Quality Engineering Specialist IV to join our Quality Engineering department. The QE will be primarily responsible for managing product development activities working closely with Analytical development, QA Ops, Quality Compliance and manufacturing organizations This position may be expected to manage a small team to ensure approval of study reports, Reference standard protocols, Deviations, Investigations, CAPA and Change Controls to meet business goals in a timely and compliant manner.

This position reports directly to the Director for Quality Engineering

Responsibilities include but are not limited to:
  • Provide Quality technical support to the internal Novavax QAops, stability Ops and QC organization as well as cross-functional Novavax teams working through product development, technology transfer, stability Ops, and/ or continuous improvement activities both internally and at our contract manufacturing and testing sites and Alliance partners.
  • Support the for Deviations, Out of Specification Notices and Change Control notices related to outsourced manufacturing and internal testing activities and provide the required Quality assessment and approval for the quality records.
  • Support Novavax technical teams by providing QA input, review, and approval to study designs, protocols, technical reports, and new program implementations.
  • Support Quality Operations during regulatory inspections and in maintenance of a state of inspection readiness.
  • Maintain working knowledge of Novavax Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
  • 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
Minimum Requirements:
  • Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8 years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience.
  • Understanding of Quality Assurance systems
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency
  • Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax
  • Capable to manage multiple priorities, adapt and maintain adherence to timelines
Preferred Requirements:
  • Demonstrated ability to lead complex development activities and investigations with minimal supervision
  • Demonstrated advanced technical knowledge
  • Demonstrated ability to lead and develop more junior employees
  • Demonstrated ability to manage process improvement projects
  • Demonstrated knowledge of GMP, GLP, GCP and GCLP expectations
  • The ability to keep colleagues apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
  • The accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments
  • The capability to assist other team members in a small number of areas and learns additional knowledge cooperatively; to build influence by completing tasks and presenting new ideas; to contribute to cross-functional work; to build relationships internally and coordinates work with others
This position may require periodic weekend/evening work.

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.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

#LI-DC

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)


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