Associate Scientist/ Process Development at Smart Biotech Solutions

The Role

• Support the cell line development  team through participation in transfection, stable selection, cloning, screening and characterization of mammalian cell lines for clinical and commercial production of recombinant proteins, monoclonal antibodies, and other novel molecules
• Perform laboratory experiments using a variety of cell culture and analytical technologies including single-cell cloning and cell imaging
• Effectively communicate results through written documentation and oral presentations to multidisciplinary teams
• Help establish new methods and technologies designed to improve and stream-line the activities of cell line development and upstream process development
• Understand project timelines and deliverables and coordinating projects within Technical Operations
• Author and review technical reports to support CMC sections for regulatory filings and assist with technical oversight for responses to regulatory agency comments/recommendations
• Support the Technical Operations Drug Substance group during tech transfers to GMP settings
• Support internal investigations and process development activities as they pertain to cell banking and cell line creation
• Effectively engage and provide support to internal Research and Development groups
• Collaborate with external partners and vendors on projects relating to cell line development

Skills

• Sc. with 4-6 years of industry experience in cell culture technologies including aseptic technique, culture of mammalian cells (CHO), single-cell cloning, clone screening, and fed batch production
• Excellent knowledge of tests for protein analysis (HPLC ProA, ELISA, Octet, etc.) is required
• Molecular biology and/or FACs experience is preferred
• Experience authoring and reviewing technical reports
• Ability to independently design, execute, and report results of experiments in a timely fashion
• Creative problem-solving ability and motivation to continually improve processes
• Ability to work independently, with minimal supervision, and to manage multiple projects at one time
• Enthusiastic with a high-level of integrity and attention to detail