Senior Research Associate

Department
Translational R&D Immunology

Location
San Diego, CA

Summary Description
PaxVax Inc. (now owned by Emergent BioSolutions) is a global specialty vaccines company focused on travel and endemic disease markets with a mission to develop and commercialize innovative vaccines against infectious diseases in a socially responsible manner. The Research Associate position will have a critical role on the Clinical Immunology testing team supporting various clinical vaccine development programs. This is a unique position requiring knowledge of GCP and ICH guidelines and CFR regulations and is responsible for laboratory testing activities in a highly regulated laboratory environment. The successful candidate will join a team dedicated for the development, qualification, and validation of pre-clinical and clinical biological assays with primary focus on virus neutralization assay testing of clinical samples. The main responsibilities will include bioassay execution, sample and data management, and reporting of data results. Must be able to able to multi-task, adapt, and be flexible in a fast-paced and demanding work environment. Documentation, organization, and accountability is key. Will work closely with Clinical Immunology, Data Management and Quality Assurance groups to ensure timely delivery of quality clinical data, project specific demands and requirements.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop, qualify, validate, and execute virus neutralization assays to support clinical trials
  • Identify and implement new assay technologies and lab automation to achieve efficient workflows
  • Develop, optimize, automate, and troubleshoot a broad range of immunoassays
  • Support pre-clinical and clinical assay laboratory activities and operations
  • Write and review technical reports, research protocols, and SOPs
  • Interact productively and efficiently with QA, QC, VCM, and laboratory safety departments

QUALIFICATIONS/TECHNICAL SKILLS:

  • Extensive experience in assay development, optimization, and execution is required
  • Industry experience with applied Biology, Cell Biology, Virology, or Immunology
  • Experience with virus neutralization, cell-based, and immunological assays
  • High-throughput multi-well assay experience including ELISA, ELISpot, neutralization a plus
  • Excellent understanding of scientific methods and statistical analysis
  • Ability to analyze complex data and come to valid scientific conclusions
  • Ability to plan project tasks effectively, keep to timeline and prioritize
  • Have strong innovation, analytical thinking, and troubleshooting capabilities
  • Be a proven team player with outstanding oral and written communication
  • Ability to collaborate with research team and perform project specific experiments
  • Productive, willing to take initiative, able to work in a collaborative team
  • Excellent technical writing skills
  • Thorough understanding of concepts related to vaccine development against infectious diseases
  • Extensive experience in Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) environments
  • Good understanding of regulatory requirements, including ICH guidelines and CFRs
  • Experience working in a regulated GCLP laboratory environment

EDUCATION AND EXPERIENCE:

  • Relevant experience in a research environment with demonstrated scientific skill sets
  • At least 2 years of clinical research experience within biotech/pharma/CRO
  • BS with a minimum of 4 years of experience
  • MS with a minimum of 2 years of experience
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