Associate Scientist, Cell Manufacturing and Process Development

If you are interested, please send you resume to Meredith.Fortener@KellyScientific.com



Location: Pasadena

Contract Length: 9 months-possibility to convert to direct hire role

The Associate Scientist, Cell Manufacturing and Process Development: will perform a broad range of tasks associated with the manufacture of cells for use in clinical and developmental studies.

• Work as part of the team to execute Process Development Activities, plan and execute laboratory studies in order to support process development, characterization or process improvements
• Adheres to laboratory quality systems, batch records, SOPs, and cGMP regulations. Accurately completes documentation associated with development activities and sample analysis and records experiments in electronic lab notebook.
• Develops and executes protocols related to cell culture, processing and other activities as needed

· Assist with Technical Transfer of methods and procedures to the Cell Manufacturing department

· Perform analytical assays (ddPCR, CFU assay, Flow cytometry) to assist with Process development

· Drafts and reviews Standard Operating Procedures (SOPs), Batch Records, technical reports, and other documents for processes, equipment and test assays.

· Assists with testing and evaluation of new Equipment and commissioning.

· Assists with routine maintenance of scientific instrumentation, and equipment as required.

· Maintains current training status for all applicable activities.

· Provides feedback to Lead Scientist and Manager

· Presents experimental data at departmental or project meetings

· Works well in a team environment, collaborates well with various colleagues in other groups such as Bioanalytics, QA and Operations

· Ensures high safety standards are adhered to as governed by local, state and federal regulations, laws and policies as well as policies and directives

Experience

· 2+ years' experience in cell /gene therapy processing, familiarity with HSC is a plus

· Experience with analytical methods to characterize in process and final cell product samples (gene marking, CFU assay, flow cytometry)

· At least three years laboratory experience in biomedical research or a clinical laboratory with an emphasis on GMP practices, validation and execution of Laboratory SOPs and QC/QA practices. Experience in cellular biology, Immunology, Hematology and/or Hematopoietic Stem and Progenitor Cell Biology (HSPC) preferred.

· Experience in cell enrichment, culture, and cryopreservation of human HSPCs

Education

· BS/MA in life sciences (Cellular Biology, Immunology, or Biomedical)

· Familiarity with GMP Manufacturing processes and working within a controlled environment

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