Assay Development Associate Scientist may supervise one or more Research Associates in the development and validation of immunoassays, showing strong decision-making abilities in their area of expertise. They create a development strategy for their own developmental projects as well as the projects assigned to their direct reports, designing experiments, troubleshooting problems, organizing, and interpreting experimental results and performing follow-up experiments. Their ability to perform sophisticated technical tasks allows them to pursue projects that incorporate a diverse set of skills and work on multiple projects/experiments simultaneously.
- Designs and executes immunoassays (e.g., ELISA) independently, based on protocols provided by literature, seminars, and other scientists. Troubleshoots assay-related problems with no guidance of his/her supervisor and performs follow-up experiments. Suggests modifications to protocols or alternative protocols.
- May supervise one or more Associate level scientists in the development and validation of immunoassays to support new programs.
- Routinely performs multiple assays within the same day and can work on multiple projects simultaneously.
- Summarizes and presents results to supervisor in a logical manner, verbally and in written reports or presentations. May present data to senior management.
- Independently develops immunoassay methods and writes assay validation protocols.
- Expertly performs validation experiments, summarizes results in a tabular manner. Writes/reviews validation reports.
- Trains other lab personnel on his/her area of technical expertise. Serves as a role model and mentor within the group.
- Communicates effectively with supervisor and other members of the Assay Development Group. Communicates with other groups within the company and/or outside vendors to obtain assay-related reagents or discuss reagents needs.
- May participate in multi-disciplinary meetings such as joint project teams as Assay Development representative to help direct drug development programs.
- May evaluate new technologies for the development of immunoassays using new formats or techniques.
- Maintains GLP compliance for all laboratory work and documentation related to assay validations in accordance with FDA regulations and company SOPs. Assists in maintaining GLP compliance in the laboratory.
- A PhD degree
- A minimum of 2 years of post-degree laboratory experience.
- Experience developing and/or validating pharmacokinetics (PK), biomarkers and/or immunogenicity (ADAs and NAbs) assays is preferred.