QA Compliance Specialist IV, Vaccine Immunology
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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.
Summary of the Position:
We are seeking an initiative-taking individual who is scientifically trained and has quality experience to join our Immunology team as part of Vaccine Immunology department located in Gaithersburg, MD. This individual will play a key role in coordinating the data sharing with the external labs, perform quality review of the data and share with the Head of the organization for the review and sharing study results with the senior management. This is a unique role, therefore qualified individual is expected to have strong scientific background, and hand on experience on the relevant assays. In addition, the ideal candidate should have strong quality experience in reviewing data, documents.
This position will be located at our Gaithersburg, MD facility and will report to the Vice President in Vaccine Immunology.
Responsibilities include but are not limited to:
- Play a key role in drafting, reviewing, and approving the external animal study and analytical testing protocol,
- Responsible for coordinating data collection from the external labs, perform quality review of the data for consistency and accuracy to ensure that results meet specifications; test procedures were followed, and laboratory work is documented appropriately
- Review all results from the assays performed on clinical samples from the quality perspective, perform data analysis and share with the Head of the organization
- Participate in the transfer and qualification/validation of analytical methods from/ to contract-testing lab as needed.
- Provide support for the regulatory audit, review, and inspection of the non-clinical and clinical study results
- Provide assistance to project team, collaborators, and technical writers in the writing, reviewing, and editing of technical documents and SOPs.
- Maintain records and inventories.
- Troubleshoot assay and instrumentation issues
- Bachelor’s or master’s degree in chemistry, biochemistry, biotechnology, or other related area is required
- 10-12 years of experience with BS and 7-10 year of experience in molecular and cell biology, immunological assays, protein chemistry and protein characterization are required; must have hand on experience preferably in immunological assays such as ELISA and FACS
- 5+ years of experience working in quality organization is required
- Experience in authoring, reviewing and approving quality documents in a quality organization is required
- Logical problem solving and the ability to manage complex projects and meet timely deadlines; effectively communicate issues/problems and results that impact timelines, accuracy, and reliability of laboratory data.
- Effectively communicate performance goals and expectations, provide coaching and facilitate problem solving methodologies to team
- Proficiency in MS Office suite, experience with standard data analysis tools and databases (Excel, Access, SharePoint)
- The ability to multi-task and work productively in a demanding environment with changing priorities.
- Demonstrated verbal and written skills in communicating regulatory and technical information with the external and internal teams is a plus
- Proficiency in use of Microsoft WORD, Excel, and PowerPoint.
- Research activities may require weekend / evening work. Candidate must be flexible in time management.
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.
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)