| Primary responsibility is support for the Assay Services subgroup within Analytical Chem. This position involves documentation of samples received for analysis and performance of a variety of analytical assays with adherence to strict timelines. Assays may include enzyme activity, total protein, cell-based bioassays, chromatography and electrophoresis, done under the supervision of more senior personnel. Assists in the qualification of assay methods and in their transfer to the Quality Control laboratories. Provides major contributions to the evaluation of drug substance and drug product. Responsible for operational aspects of the laboratory through ordering, equipment maintenance and organization.|
Scope: Data generated is used for lot release and stability evaluation of clinical batches of drug substance and drug product. Data generated is also used in decisions involving process development/formulation projects.
Receives, documents sample submission and records results for Assay Services in support of a variety of different groups including QCCS, Cell Culture PD, Purification PD and Formulation.
Performs analytical assays for samples within and outside the purview of assay services. Including enzyme activity, total protein by Bradford or A280, cellular uptake bioassays, gel and capillary electrophoresis and HPLC methods.
Under appropriate supervision, assists Research Associates and Scientists in the qualification of assay methods for transfer to the Quality Control Analytical and In-Process laboratories.
With increasing experience, develops the capacity to troubleshoot assay methods and to suggest remedies for problems or improvements to the methods.
Other duties as assigned.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Primarily a laboratory position; contact with chemicals is part of the job. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job.
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.
Extensive experience with several different assay techniques.
Accurate recording and reporting of assay results.
Development of assay troubleshooting skills, both general and technique-specific
Demonstration of aptitude and interest in assay development.
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