Scientist I/II, Clinical Immunology (Assay Development/Validation)
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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 a highly motivated, experienced and detailed oriented individual to serve as a Scientist in the Clinical Immunology department with a focus on assay development and validation for viral cell-based assays such as microneutralization assays in GCLP environment.
Responsibilities include but are not limited to:
- Serve as a key person on the scientific team in Clinical Immunology vaccine programs for Influenza, and COVID-19 and any new or emerging vaccine programs.
- With the oversight of senior scientists, design and conduct scientific and technical experiments for bioanalytical assay development, optimization, qualification, validation, troubleshooting and life-cycle management.
- Responsible for development of cell-based viral neutralization assays, ELISA-based assays, or other relevant serological assays.
- Mammalian cell culture and characterization and creation of working cell banks.
- Support the development and implementation of improved sample throughput via new technologies and automation.
- Provide scientific and managerial capabilities to the assigned project.
- Design, implement, help to execute and oversee study objectives within the assigned project with minimal supervision, lead a team of research associates and provide training as needed.
- Author and review documentation associated with project objectives including project specific technical reports, standard operating procedures, work instructions, protocols, and transfer reports.
- Contribute to scientific publications and presentations as needed.
- Help to prepare clinical and regulatory agency documents as needed and participate in the review process of these documents. Provide selected sections for FDA regulatory BLA filing.
- Ensure all clinical testing performed is compliant with regulatory, QA and GCLP internal requirements and quality systems.
- Investigate and ensure timely closure of Quality events, deviations and maintain CAPA plans.
- Work with automated systems (such as Robotic liquid handling), system integration and software programming.
- Oversight of critical reagents, equipment validation relevant to assay/projects.
- Cost-effective management of assay material and reagent inventories.
- Work closely with sample management team to ensure compliance of team for clinical sample storage and security following SOPs.
- Ensuring use of calibrated equipment by team following GCLP guidelines and internal SOPs.
- Assist senior management with projecting, and adhering to, budgets for clinical immunology laboratory operations.
- As SME & scientist on project would be expected to present scientific findings and data at internal meetings within and outside the department as needed.
- Plan and work independently with minimal supervision under the direction of a Senior Scientist.
- Collaboration with colleagues from Discovery/Preclinical, quality systems (CQA), Clinical Operations Biostatistics, IS/IT and Regulatory Affairs.
- Continuing internal and external vigilance for new methods, or improvements of existing methods that may enhance Novavax’ clinical assay capabilities.
- Responsible for a lab team of 2 or more direct reports.
- Scientist I, ideally PhD with 0-2 years relevant post-doctoral experience or MSc with 6 years + of directly relevant or BSc with 8 + years in Biology, Immunology, Microbiology, Molecular Biology, or related field in GCLP Clinical Immunology Lab or other related areas in Biotech or Pharma Industry setting.
- Scientist II expected to have PhD with 2 years + (post-doctoral experience) or MSc 8 years + experience in Biology, Immunology, Microbiology, Molecular Biology, or related field in GCLP Clinical Immunology Lab or other related areas in Biotech or Pharma Industry setting.
- Extensive experience in cell-based viral neutralization assays and mammalian cell culture required.
- Must have experience in development, qualification/validation of relevant virological and immunological assays in GCLP environment.
- Experience with management and development of direct reports.
- Understanding of GCLP requirements and other FDA regulatory requirements associated with clinical testing.
- Team player who is well organized with excellent interpersonal and oral/written communication skills and be able to perform multitasking as needed.
- Ability to work effectively with cross-functional groups.
- Ability to work independently on projects with minimal supervision and lead a team of research associates.
- Good computer skills and experience with relevant software such as SoftMax, Excel, PowerPoint, ability to analyze data using statistical tools (e.g., JMP, Prism).
- Previous experience working in a fast-paced high throughput clinical assay lab (GCLP) and use of LIMs advantageous.
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)
Gaithersburg, Maryland, USA
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