| Job Description | QC Analyst / Assay Development Associate
We are currently seeking a Quality Control Analyst/Assay Development Associate to work in the Process Technology Development group to perform QC testing and Assay Methods Development activities to support ongoing clinical programs. This position reports to the Manager, QC and Assay Methods Development.
Responsibilities will include:
· Perform raw material, final product and/or in-process quality control testing for clinical, non-clinical, validation, stability, and comparability studies
· Participate in assay methods development, qualification and validation protocols as required
· Assist with preparing SOPs, results summaries, assay/equipment qualification and validation protocols, reports and other documentation
· Maintain QC laboratory and inventory for GMP Operations
· Prepare, test and maintain analytical reference cell banks and other reference standards for use in functional assay methods for QC release and stability testing
· Assist in the transfer, qualification and validation of test methods for identity, purity and potency (e.g. FACS; biochemical; molecular)
· Coordinate sample distribution and results compilation for extended characterization or other informational testing with internal R&D groups or other external vendors
· Keep accurate and complete records per cGMP and compile trending reports as required
· Other duties as may be assigned
Candidate must possess:
· A BS in cell biology, biochemistry or a related discipline
· 2 to 5 years of biotech company experience
· Hands-on experience testing biotechnology and/or cell-based products (primary cells and mammalian cell culture, cell based assays) and biological raw materials (cytokines, antibodies, enzymes)
· Solid organizational skills and familiarity with USP/EP compendia, cGMP, GLP, and ICH guidelines
· Solid understanding of and experience with QC routine and cell based assays; endotoxin testing, plate-based immunoassays; FACS analysis, primary cell characterization, and relevant laboratory instrumentation.
· Understanding of GTP, cGMP and ICH regulations, guidelines and documentation requirements
· Familiarity with USP and EP compendia
· Must have excellent organizational, written communications and oral communication skills
· Must be a motivated team player
· Must be willing to work flexible hours |
| | Company | | StemCells, Inc. | Job Code | | State or Province | | California | | |
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