Kelly Services Scientist - San Diego, CA in San Diego, California
Scientist - San Diego, CA
We are currently seeking a Scientist in Cell Therapy. This position will support in-process-control and QC release assay development for stem cell therapy manufacturing related to induced pluripotent stem cell (iPSC) derived dopaminergic progenitor cells of a first-in-human clinical trial for the treatment of neurodegenerative diseases.
Essential Duties and Responsibilities:
Work within a cross-functional team of scientists, engineers, bioinformatic specialists and research/development associates
Design, develop or refine, execute and document analytical methods to study and characterize processes for production of autologous iPSC-derived cell therapies
Oversee testing and review of Environmental Monitoring data of GMP facility
Ensure proper tracking and storage of test samples and associated controlled documentation
Prepare SOP, qualification protocols, reports and other documentation
Ensure SOP, analytical test methods, analytical sampling plans and batch records meet industry standards
Other duties and responsibilities as assigned
Master's degree (MS) or higher in Cellular / Molecular Biology or Biochemistry / Chemistry. Advanced degree is preferred.
Minimum of 5+ years hands-on, Quality Control group assay development and qualification experience in a GMP environment
Expertise with analytical method development and qualification/validation, and analysis of cell therapy products
Knowledge of cGMP guidelines and compliance in QC lab (environmental monitoring, audits, CAPA, OOS and deviation events)
Experience with cell-based, ELISA, flow cytometry and quantitative PCR assays (advanced genomic assays: WGS, RNAseq and SNP arrays a plus)
Knowledge of statistical methods applicable to the analysis of experimental data
Must be willing to work flexible hours
For immediate consideration, apply today! Questions? Contact Toni at 714 454 8252 OR TONM369@kellyservices.com
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