Senior QC Analyst/Assay Development Associate

Job Description
We are currently seeking a Senior 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:

•Develop, transfer, qualify and validate test methods for identity, purity and characterization/potency for HuCNS-SC® cell banks and cell-based therapeutic final products

•Prepare, test and maintain analytical reference cell banks and other reference standards for use in QC test methods for elease and/or stability testing of raw materials, reagents and intermediates per cGMP/ICH requirements
•Perform QC release and stability testing of raw materials, reagents, intermediates and cell-based therapeutic final products
•Define, execute and report prospective stability trial programs for raw materials, reagents, intermediates and cell-based therapeutic final products
•Coordinate sample distribution and results compilation for extended characterization or other informational testing
•Maintain and operate QC equipment per cGMP/ICH requirements
•Write and revise test methods SOPs, test results forms, instrument SOPs and other documentation as needed
•Other duties as may be assigned

Candidate must possess:

•A BS in cell biology, biochemistry or a related discipline
•A minimum of 8 years of relevant experience developing, validating and implementing assay test methods in support of the development, GMP manufacture and clinical evaluation of biologic products in the biotechnology industry
•Strong work ethic and a proven ability to manage multiple projects and work well in a multi-discipline project team
•In-depth knowledge of FACS analysis, in-vitro cell-based biological assays, immunoassays, protein analytical and characterization methodologies, and primary cell characterizations
•Demonstrated knowledge of molecular biology techniques, USP/EP compendial test methods, all relevant laboratory instrumentation and GLP, cGMP and ICH regulations and guidelines
•Ability to critically analyze data, proactively solve problems and make recommendations
•Must be able to author, understand and follow complex written procedures
•Must have excellent organizational, written communications and oral communication skills
•Must be a motivated team player
•Must be willing to work flexible hours


StemCells, Inc.

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