1 DNA Way South San Francisco, California 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Biological Technologies (BT) is responsible for the development/optimization, validation, transfer, and technical support for biological test methods used for QC clinical and commercial product.
- The group also supports lot release/stability testing of all clinical products and potency testing for process development and product characterization.
- The job responsibilities within BT are to provide general support of the activities in GMP testing laboratories.
- This includes but is not limited to: equipment maintenance and verification; routine “ sweeps” of the lab to ensure compliance with cGMP, GLP and safety regulations; ordering, stocking and maintaining supply levels in the laboratories; maintenance of human cell culture lines; participation in testing or development of biochemical/immunological/biophysical and cell-based assays in support of process development, clinical and to-be-marketed products.
- Expectations include use of various Process Explorer, SoftMax Pro, Labware LIMS maintenance of labs via Lean tools such as 5S and Environmental, Health, and Safety practices, routine lab maintenance, and project support/equipment qualification/computer systems/document management as needed.
- Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skills for a fast paced environment is a must.
- Must also be dependable and able to work with minimal supervision.
- Familiarity with basic laboratory equipment is preferred.
- Experience with performing immunological or cell-based assays, aseptic cell culturing, DOE/familiarity with JMP analysis, reporter assay, and cGMP familiarity/knowledge a plus.
- Good computer skills are required, and experience working with Labware LIMS, EDMS DocLink, and Trackwise are recommended.
- Requirements: B.S. in Biological Sciences.
- 1-2 years of relevant experience in Quality Control, preferred.