QC Method Development Scientist

We are currently seeking a QC Method Development Scientist, 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 Parkinson’s Disease sponsored by Aspen Neuroscience, Inc. This newly created role reports to the Senior Director of Manufacturing.

Responsibilities will include:

  • 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

Essential Qualification and Skills required:

  • MS degree 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

Aspen Neuroscience, Inc. offers a competitive compensation package, as well as time-off in addition to Company observed holidays, and Medical/Dental insurance benefits. We promote a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.

To apply, please send your cover letter and resume to tgorba@aspenneuro.com, Subject: QC Method Development Scientist