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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

Job Requirements:

  • 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

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About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

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