300 Bel Marin Keys Boulevard Novato, CA 94949
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
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
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.
Education and Experience:
- Four-year degree in a biological or physical science, with typical academic laboratory classes.
- 0-3 years’ experience in biological or chemical laboratory work.
- Knowledge and experience in lab processes and procedures. Experience with cell culture sterile technique is preferred.