Scientist, Clinical Immunology

SUMMARY:

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 Scientist position will have a critical role on the Clinical Immunology testing team supporting various clinical vaccine development programs. This unique position requires extensive knowledge of GCLP compliance, ICH guidelines and CFR regulations which govern our laboratory processes and the individual will be responsible for overseeing and executing laboratory testing activities in a highly regulated laboratory environment. The successful candidate will join a team dedicated to 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, documentation, 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. GxP-compliant documentation, organization, and accountability are 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, the individual must be able to perform each essential duty effectively. 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 propose 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
• Participates in the development of patent applications and relevant scientific publications
• Work productively and collaboratively with other research scientists to achieve compliant and top-quality outcomes from clinical assay testing development and execution
• Demonstrate outstanding and exemplary conduct for strictly adhering to compliant procedures
• Proactively engages with team members to suggest improvement to current procedures
• Support of intradepartmental research efforts and related activities
• Interact productively and efficiently with QA, QC, VCM, and laboratory safety departments
• Investigates and researches current science, new findings, and new techniques to stay abreast of the industry

QUALIFICATIONS/TECHNICAL SKILLS:

• Extensive experience in Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) environments
• Experience working in a regulated GCLP laboratory environment
• Excellent technical writing skills
• Experience with virus neutralization, cell-based, and immunological assays
• Extensive experience in assay development, optimization, and execution is required
• Demonstrated experience with strict adherence to compliant procedures
• Industry experience with applied Biology, Cell Biology, Virology, or Immunology
• 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
• Thorough understanding of regulatory requirements, including ICH guidelines and CFRs
• Ability to plan project tasks effectively, keep to timeline and prioritize
• Have strong innovation, analytical thinking, and troubleshooting capabilities
• Ability to present effectively to internal and external audiences
• 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
• Thorough understanding of concepts related to vaccine development against infectious diseases

EDUCATION AND EXPERIENCE:

• PhD or MS with 6 years of experience in a compliant clinical testing environment
• BS with 8 years of relevant experience in a compliant clinical testing environment