Principal Associate, Research

San Diego, CA, US
Jun 04, 2020
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
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.

Position Summary

The Principal Associate 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 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.

Essential Functions
  • 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
  • Participate 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 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, VCM, and laboratory safety departments
  • Investigate and research current science, new findings, and new techniques to stay abreast of the industry

Minimum Education, Experience, Skills
  • MS with 6 years of experience in a compliant clinical testing environment or BS with 8 years of relevant experience in a compliant clinical testing environment
  • 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

Physical/Mental Demands and Work Environment Characteristics

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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.