Assay Development Associates (ADA) at this level executes experiments under limited supervision, following written or verbal instructions. They are expected to have a mastery of general laboratory techniques, such as pipetting and making solutions, in addition to direct experience performing immunoassays. They may begin to organize and interpret data more independently and suggest follow-up experiments.
* Executes immunoassays (e.g., ELISA) under limited supervision, based on protocols provided by literature, seminars and other scientists. Troubleshoots assay-related problems with assistance of his/her supervisor.
* May perform multiple assays within the same day.
* Summarizes and presents results to supervisor in a logical manner, verbally and in written reports.
* Develops immunoassay methods under supervision and writes assay validation protocols for review by supervisor and/or Study Director prior to submission to Quality Auditing (QA).
* Communicates with QA to schedule critical phase audits for validation studies.
* Performs validation exercises and summarizes results in a tabular manner. May draft validation reports and SOPs for review by the Study Director.
* Performs Long Term Stability studies for validated methods.
* May train on validated ELISA methods with limited supervision and perform sample analysis, if needed.
* May be responsible for the preparation of reagents and buffers for use within the Assay Development Group, if needed.
* Communicates effectively with supervisor and other ADAs within the Assay Development Group.
* Effectively operates a range of laboratory instrumentation and may perform instrument verifications and/or maintenance if required.
* 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.
* Maintains cleanliness of individual and communal work areas.
* Learns and complies with safety requirements of his/her laboratory. Recognizes potential safety problems and takes action to correct them.