Scientist - Analytical Development

Company/Position Description:

Our client's Analytical Development group is looking for a highly motivated and talented Research Scientist (RS) with a background in immunology, cancer biology, stem cell (iPSCs and HSPCs) biology, and cell therapy scientific principles, to lead the development of cell-based potency assays for their innovative broad-spectrum CAR based therapy pipeline.

The ideal candidate will have an extensive experience in method development, qualification/validation of immunoassays and cell-based assays. The successful candidate will work as an individual contributor and generate, analyze, interpret, present experimental data, and carefully document resultant information.

Responsibilities:

• .Drive the project by independently designing, executing and documenting analytical method development and qualification/validation to support of process development, product release and stability, and product characterization of cell therapy drug products
• Employ quality by design (QbD) and design of experiment (DOE) approaches for method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
• Serve as a SME for Analytical Development and responsible for knowledge/tech transfer of product characterization/release methods across our client's sites.
• Use forward looking perspective to contribute towards strategic (go/no-go) decisions as well as recommend new technologies for the Process Development team to pursue.

Requirements:

• PhD/MS/BS in Cellular Biology, Immunology or Molecular Biology
• In-depth knowledge of iPSCs/NK-cell biology and immune cell therapy
• Proficiency in designing and optimization of immune cell (NK/iNKT) potency/functional assays.
• Experience in tumor cell line characterization and cell-based assays assessing tumor cytotoxicity analysis, immune-cell activation/proliferation and cytokine secretion profiling etc. is strongly desired.
• Expertise in aseptic mammalian cell culture, human immune cell isolation and expansion is required.

Compensation Package:

• Relocation Package
• Competitive base salary plus a bonus based on individual and company performance
• 401K with Company match & RSUs/Stocks
• Extensive PTO plan including vacation, holidays and sick time
• Healthcare plan including: Health, Vision, Dental
• Short & Long term disability
• Internal product training & career growth programs

If you are interested in joining our client's world class team, or know someone who is, please apply to the position below or email me at cporter@gtscareers.com