Senior Research Associate, Clinical Immunology
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Senior Associate position will have a critical role on the Clinical Immunology testing team supporting various clinical vaccine development programs. This position requires knowledge of GCLP compliance 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 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 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.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Perform routine pre-clinical and clinical laboratory assays
• Support the development, qualification, validation, and execution of virus neutralization assays to support clinical trials
• Support the development, optimization, automation, and troubleshooting of a broad range of immunoassays
• Write and review technical reports, research protocols, and SOPs
• 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 engage with team members to suggest improvement to current procedures
• Support of intradepartmental research efforts and related activities
• Interact productively and efficiently with QA, QC, and laboratory safety departments
• Investigate and research current science, new findings, and new techniques to stay abreast of the industry
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• MS with 2 years of experience in a compliant clinical testing environment or BS with 4 years of relevant experience in a compliant clinical testing environment
• 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
• Experience in assay development, optimization, and execution
• 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, cell-based assays a plus
• Excellent understanding of scientific methods
• 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
• General understanding of concepts related to vaccine development against infectious diseases
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
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Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.