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.
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Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual with method investigation and analytical technology transfer experience to join us as a Sr. Manager, Analytical Ops, at our Santa Monica, California location.
In this role, you will work with Process Development, Clinical and Commercial Quality Control to provide leadership to a team responsible for transfer and implementation of new methods including assay automation, facilitate the introduction of new equipment, and establish systems for global site collaboration for method performance.
Responsibilities include (but are not limited to):
- Lead Commercial analytical technology transfer for new programs, external partners, and new site buildup
- Work with analytical development teams, identify opportunities to improve assay performance and throughput, and improve the overall efficiency of analytical testing utilizing Lifecycle Management (LCM)
- Provide leadership to support troubleshooting in Commercial Quality Control and external partners during and post technology transfer
- Develop a team of technical experts to perform root-cause investigations for deviations and CAPAs relating to analytical methods
- Perform gap and risk assessments for analytical methods and aim to enhance compliance and robustness
- Design robust processes for method monitoring and evaluate data to ensure reduction in invalid assays
- Ensure standard operating procedures, analytical test methods, analytical sampling plans, batch records, and monitoring, trending and improvement processes for all analytical methods meet the highest industry standard
- Work with a cross-functional development team to advance development of T cell therapy products
- PhD OR
- Master's degree in Biotechnology, Bioengineering or another life-science discipline with 6+ years of industry experience in analytical development, Quality Control, technology transfers and method lifecycle management OR
- Bachelor's degree in Biotechnology, Bioengineering or another life-science discipline with 8+ years of industry experience in analytical development, Quality Control, technology transfers and method lifecycle management OR
- High School Diploma with 12 years of industry experience in analytical development, Quality Control, technology transfers and method lifecycle management
- 1+ years' experience leading a cross-functional, diverse, experienced technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem solving skills, and work with and lead others
- In-depth experience with analytical method development, CMC technology transfer and cGMP requirements, and testing in Clinical and Commercial Quality Control
- Extensive experience in analytical development and transfer, including in operational and technology focused roles.
- Experience with Root Cause Analysis (RCA) methodologies and tools
- Knowledge and experience with method related deviations, change controls, investigations and method performance metrics
- Knowledge and understanding of FDA, EMEA and other global regulatory compliance guidelines
- Experience in analytical techniques such as Flow cytometry, qPCR, ddPCR, ELISA and microbiology techniques
- Proficient in MS Word, Excel, Power Point, JMP, and other applications
- Ability to function efficiently and independently in a changing environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
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 .
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.