QC Analyst / Assay Development Associate

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


StemCells, Inc.

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