Description
Military Veterans are Encouraged to Apply.
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
Analytical development is seeking a talented and highly motivated individual with flow cytometry and cell based analytical method development experience to support the Kite's innovative allogeneic cell therapy pipeline for cancer treatment. The successful candidate will be a part of team responsible for the development and technology transfer of analytical methods for a broad spectrum of allogeneic cell therapy products to support process characterization and product release. The ideal candidate will have strong knowledge of immunology, cancer biology, stem cell biology, or cell therapy scientific principles. As an independent contributor, the candidate will be responsible for the designing, planning and execution of flowcytometry analytical methods and cell-based bioassays using Quality by Design (QbD) and Design of Experiment (DoE) approaches. The candidate will serve as SME and plan, execute flow cytometry and cell-based assays, 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. In collaboration with Research and Translational Medicine, the Research Scientist will work cross-functionally to identify new technologies and opportunities for continuous process/product improvement.
This role has a significant scope of growth which will evolve and expand over time to include mentoring junior team members. Functioning as a T- and/or NK-cell biology SME, the candidate will work with key stakeholders to build and advance product characterization workflows to enhance product understanding.
Responsibilities and Duties
- Independently design, execute and document analytical method development and qualification/validation for release, stability, and characterization methods of allogeneic cell therapy drug products.
- Lead the method optimization, perform data analysis, data review, data reporting and troubleshooting of flow cytometry and cell-based potency release and characterization methods.
- Serve as SME for AD and responsible for knowledge and technology transfer for in-process characterization and product release methods within Kite and its external partners.
- 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 agencies.
- Author, review and edit technical documents, including SOPs, protocols and reports.
- Maintain, calibrate and operate flow cytometry analytical equipment and instruments.
- 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 flow cytometric and cell based analytical methods.
- 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+ yearsof industry/research experience or
- MS with 6+ years of industry/research experience or
- BS with 8+ years of industry/research experience.
Preferred qualifications - Strong scientific background in immunology, cancer biology or cell biology.
- In-depth knowledge of T- and/or NK-cell characterization and functional assays (eg. activation/proliferation, exhaustion, senescence etc.) is strongly desired.
- 3+ years experiences in flow cytometry (8+ or more color) in academia or industry.
- Technical proficiency in flow cytometric panel designing, compensation setup, multi-color (8+ colors or more) data analysis and interpretation and instrument trouble shooting is essential.
- Experience in analytical method development and qualification of cell and flowcytometry based potency assays is preferred.
- Proficiency in flow cytometry software, such as FlowJo, FACSDiva, CytExpert, FACS Express etc. is required.
- Experience with aseptic primary cell culture techniques is required.
- Skills and knowledge in qPCR, ddPCR and ELISA is a plus.
- Knowledge of QbD approaches to analytical method development including risk and gap assessments, DOE and statistical analysis is a plus.
- Ability to think critically with strong analytical and problem-solving skills and excellent organization and communication skills.
- Previous experience with cell therapy products and understanding of GxP is a plus.
- Excellent skills in Microsoft Office, data analysis softwares (e.g. JMP, Graphpad Prism, Geneious, SoftMax Pro), and other applications
- Evidence of high level of scientific expertise demonstrated through scientific publications, literature review and scientific conference participation is preferred.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to on Twitter at .
For jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.
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For Current Kite Pharma Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
