ProClinical is recruiting for the open, contracted position of Scientist I – Analytical Development, Immunoassay for our client, a clinical-stage vaccine company based in Gathersburg, MD. The ideal candidate for Scientist I will join their Analytical Development Department in Gaithersburg, MD. The qualified individual should have extensive experience with ELISA-based immunoassays, and the position requires initiation and involvement in the development and qualification/validation of quantitative immunoassays for vaccine products and process-related impurities (host cell proteins). The ideal candidate will make detailed observations, analyze data, interpret results, write qualification/validation reports and SOPs, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments. The candidate will receive general instructions from a supervisor and will work independently, as well as collaborate with other team members and other groups.
- Develop immunoassays (ELISA) and label-free binding assays (SPR) for analysis and biological characterization of virus-like particle and protein nanoparticle vaccine products and process-related impurities (host cell proteins)
- Responsible for preparation and characterization of host cell protein (HCP) standards and specific antibodies
- Responsible for determination of process-related impurities.
- Perform characterization studies to understand potential impact of impurities on safety and immunogenicity.
- Apply new cutting-edge technologies for in-process testing and product biological characterization. Experience with Surface Plasmon Resonance (SPR) is highly desired
- Support Discovery testing needs for the projects in the pipeline
- Perform method qualification/validation, and method transfer to other departments (e.g. QC)
- Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays
- Maintain effective communication with process development, formulation, QC, discovery, and clinical groups
- Write, review, and edit SOPs and qualification/validation reports
- Prepare technical reports and scientific journal publications and presentations. Provide selected sections for CMC regulatory filing
- Present scientific findings at internal meetings and external conferences
- Preparation and characterization of critical reagents and data trending
Skills And Requirements
- Master’s degree with 5 years’ experience in related field, or Ph.D. in biological science with minimum of 2 years’ experience in related field.
- Thorough understanding of immunoassay, enzyme assays, and label-free binding techniques in protein analysis.
- Ability to critically analyze data using statistical tools.
- Proficient in Microsoft Excel and/or other statistical tools to critically analyze data.
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
- Ability to work effectively with cross-functional groups.
- Ability to prepare technical reports and presentations.
- Understanding of GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products.