Scientist - Analytical Development Bioassay
Company: Kite Pharma
Location: Santa Monica
Posted on: June 20, 2022
Job DescriptionKite Pharma Analytical Development 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 Kite's innovative
broad-spectrum CAR based therapy pipeline. The ideal candidate will
have an extensive experience in HTP method
development/qualification/validation of cell-based potency assays
utilizing tumor cell cytotoxicity, flowcytometry and cytokine
secretion analysis utilizing ELISA/proximity binding assay
platforms. The successful candidate will be responsible for
independently designing, planning and executing analytical method
development of immunoassays and cell-based bioassays using Quality
by Design (QbD) and design of experiment (DOE) approaches.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. The RS will serve as SME
and author/review/edit test methods, SOPs, technical reports, and
assist in the technical review of CMC sections and supporting
documents for regulatory filings.
Responsibilities and Duties:
- 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
- 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 Kite 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.
- Participate as a key member in cross-functional teams that
align on strategies to characterize in-process and product
attributes in Kite cell therapy products.
- Function independently in non-routine development activities
and project goals.
- Author and review technical documents (e.g., development
reports, SOPs, and technical reports).
- Maintain accurate documentation of experiments in ELN and
- Function as a key contributor to Process Development knowledge
by remaining up to date on scientific literature and the newest
developments in relevant fields.
- Effectively communicate scientific findings pertaining to
process/drug development via external and internal presentations,
publications, patents, white papers, etc.
- Demonstrate leadership traits through team participation,
internal consulting, and mentoring of junior team members.
- Work closely with quality associates during knowledge, method
transfer and co-qualification and/or validation.
- Develop experimental approaches using new analytical
- Maintain, calibrate and operate analytical equipment and
- Ensure that departmental areas are maintained per 5S
- PhD in Cellular Biology, Immunology or Molecular Biology with
0+ years of industry/research experience or
- MS with 6+ years of industry/research experience or
- BS with 8+ years of industry/research experience.Preferred
- In-depth knowledge of iPSCs/NK-cell biology and immune cell
- 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
- Expertise in aseptic mammalian cell culture, human immune cell
isolation and expansion is required.
- Experience in flow cytometry and acquisition/analysis
software's such as FACSDiva, CytExpert, etc. is a plus.
- Experience in analytical method development, qualification, and
validation of co-culture and plate-based immunoassays (e.g. ELISA,
Luminex, MSD, proximity binding, etc.).
- Experience on molecular assay including qPCR, ddPCR is a
- Knowledge of QbD and DOE approaches to analytical method
development and statistical analysis.
- Excellent skills in MS Office and data analysis software (e.g.
JMP, Graphpad Prism, FlowJo, SoftMax Pro) and other
- Ability to think critically and demonstrate troubleshooting and
- Evidence of high level of scientific expertise demonstrated
through scientific publications, and scientific conference
participation is preferred.
- Overall understanding of drug development process and its
impact on projects, goal and timelines is preferred.
- Experienced in establishing and maintaining internal and
external collaborations, especially with outside centers of
excellence in field of specialization.
- Excellent oral and written communication and presentation
- Understanding of GxP is preferred.
Keywords: Kite Pharma, Santa Monica , Scientist - Analytical Development Bioassay, Other , Santa Monica, California
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