Scientist, Analytical Development
Company: Kite Pharma
Location: Santa Monica
Posted on: May 13, 2022
Job DescriptionAnalytical development is seeking a talented and
highly motivated scientist with experience in analytical method
development of cell-based potency/safety assays for Kite's
innovative autologous and allogeneic cell therapy pipeline for
cancer treatment. The successful candidate will be a part of team
responsible for the development and technology transfer of cell
based analytical methods for a broad spectrum of CAR-based cell
therapy products to support process characterization and product
release. The ideal candidate will have strong knowledge of
immunology, cancer biology, or cell therapy scientific principles.
As an independent contributor, the candidate will be responsible
for the designing, planning and execution of cell-based analytical
methods using Quality by Design (QbD) and Design of Experiment
(DoE) approaches.The candidate will plan, execute, analyze and
review experimental data, and carefully document resultant
information and assist in the technical review of CMC sections and
supporting documents for regulatory filings. The candidate will
serve as an SME on cell-based assays on cross-functional teams and
in interactions with external organizations and deliver QC-viable
cell-based potency assays for transfer to clinical and commercial
sites.Responsibilities and Duties
- Independently design, execute and document analytical method
development and qualification/validation for release and stability
methods for CAR-based cell therapy drug products.
- Lead the method optimization, perform data analysis, data
review, data reporting and troubleshooting of potency release
- Serve as SME for AD and responsible for knowledge and
technology transfer for product release methods within Kite and its
- Employ quality by design (QbD), design of experiment (DoE), and
statistical approaches to method development to identify robust
operating regions within phase-appropriate pre-defined acceptance
criteria aimed to meet ICH guidelines.
- Prepare data packages for submission to regulatory
- Author, review and edit technical documents, including SOPs,
protocols and reports.
- Maintain, calibrate and operate analytical equipment's.
- Use good documentation practices (GDP) to document laboratory
activities and ensure data integrity.
- Provide user training on instruments, sample analysis, and
cross-train analysts on cell based analytical methods.
- Work closely with clinical and commercial QC during knowledge,
method transfer and co-qualification and/or validation.
- Maintain laboratory per 5S guidelines and assist with other
assigned laboratory administrative duties.
- Additional responsibilities may be assigned to reflect changes
in business process.Basic qualifications:
- 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
- Strong scientific background in immunology, cancer biology or
- In-depth knowledge of T-cell functional assays (e.g.
activation, proliferation, cytokine profiling, etc.) is strongly
- Proficiency in aseptic human immune and tumor cells, co-culture
cytotoxicity assays, cell growth analysis is required.
- Experience in clonal cell selection and cell banking principles
- Comprehensive understanding of ELISA, FRET and other proximity
binding assays is required.
- Experience in flow cytometry and good understanding of
acquisition software's such as FACSDiva, CytExpert, etc.
- Experience in analytical method development and qualification
of cell-based potency assays is preferred.
- Knowledge of QbD approaches to analytical method development
including risk and gap assessments, DOE and statistical analysis is
- Ability to think critically with strong analytical and
problem-solving skills and excellent organization and communication
- Previous experience with cell therapy products and
understanding of GxP is a plus.
- Excellent skills in Microsoft Office, data analysis software's
(e.g. JMP, Graphpad Prism, SoftMax Pro, FlowJo), and other
- Evidence of high level of scientific expertise demonstrated
through scientific publications, literature review and scientific
conference participation is preferred.
- Excellent written communication skills as demonstrated through
technical report writing and/or regulatory filings.
- Highly organized, attention to detail with ability to focus and
deliver in a fast-paced environment.#LI-ML1#IND123
Keywords: Kite Pharma, Santa Monica , Scientist, Analytical Development, Other , Santa Monica, California
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