Senior Associate Scientist, Translational Medicine
美国 - 加利福尼亚州 - 圣莫尼卡研究正式员工职位描述
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
We are seeking a highly motivated Senior Associate Scientist to join our flow cytometric analysis team. As a member of Clinical Pharmacology and Translational Medicine department, you will be at the intersection of Research and Clinical Development, providing valuable flow cytometric insight for the function of CAR-T cells in patients. You will be responsible for developing and executing fit-for-purpose assays for use in both First-in-Human and pivotal clinical trials, act as an internal subject matter expert, and liaise with our external academic and CRO partners.
Your responsibilities will principally consist of the generation of clinical trial data utilizing flow cytometry. You will perform clinical sample analysis, laboratory proficiency and organization. This role will further involve close collaboration with Clinical and Biomarker Operational teams on patient sample tracking and data quality control. The insights generated will be utilized to inform our research and clinical development efforts.
Job Responsibilities
- Design, optimize, and execute flow cytometry assays for characterization and function of immune cells and CAR-T cells derived from patients pre and post-treatment
- Support flow cytometric assay qualification and validation in a GxP environment
- Support exploratory immunophenotyping in collaboration with Translational Research colleagues
- Write, review, and edit technical documents including SOPs, development/qualification protocols, and reports
- As needed, support a wider breadth of clinical trial biospecimen PK and biomarker analysis and data acquisition using multiple immunoassay and molecular platforms (i.e. ELISA, MSD, Luminex, Simple Plex Ella, ddPCR)
- Support assay transfer internally and to contract-research labs (CRO)
- Support the preparation of data packages for publication, presentation, and submission to regulatory agencies
- Stay current with, evaluate, and adopt emerging technologies, tools, and applications to ensure fit-for-purpose and impactful approaches to the assessment of Kite’s engineered T cell therapies
- Troubleshoot technical issues and recommend potential corrective actions
- Perform analytical instrument and software validation activities in a GxP setting
- Assist Clinical Pharmacology Scientists in identifying and reconciling biospecimen inventory
- Write, review, and edit technical documents including SOPs, development/qualification protocols and reports
- Data preparation for safety and regulatory review
- Develop analysis templates and protocols in a LIMS system
- Track biospecimen analysis needs and sample inventory using laboratory information management systems (LIMS)
Basic Qualifications
Master’s and 3+ years of scientific experience
OR
Bachelor’s and 5+ years of scientific experience
OR
High School Diploma/GED and 9+ years of scientific experience
Preferred Qualifications
- Ph.D. with demonstrated experience in immunology or immuno-oncology
- Hands-on experience with sterile technique and culturing cell lines/primary cells
- Comfortable in a fast-paced environment and able to adapt to changing priorities
- Familiarity with clinical testing in a GxP environment and/or assay validation parameters
- Knowledge of electronic record keeping or Laboratory Information Management (LIMS)
- Experience with clinical biomarker discovery
- Familiarity and hands-on experience in the areas of tumor biology, immunology and immuno-oncology and related technical skills (molecular biology- ddPCR, qPCR, next-generation sequencing, RNAseq, cell culture, PBMC, immune cell isolation or functional T cell assays)
- Hands-on Expertise in multi-parameter or high dimensional flow cytometry and data analysis including commercial flow cytometry software (BD FACS Diva, FlowJo)
- Experience working with human clinical samples (eg blood, PBMCs, serum, CSF, plasma)
- Experience using visual data science platforms, such as Spotfire, GraphPad Prism, or Rstudio for data analysis and visualization
- Experience coordinating analysis and communication with vendors/CROs
- Strong team player, excellent organization and communication skills as well as strong problem solving and analytical skills, ability to work in a matrix environment
- Microsoft Office (Word, Excel, and PowerPoint) skills
The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.