Senior Associate Scientist, Analytical Operations

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 04, 2020
Ref
R0015618
Required Education
Masters Degree/MBA
Position Type
Full time
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

We are seeking a highly motivated individual with method investigation and analytical technology transfer experience to join us as a Senior Associate Scientist, Analytical Operations, at our Santa Monica, California location. The individual will work with Process Development and 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. The individual shall possess extensive experience in analytical development and transfer, including in operation and technology focused roles.

Responsibilities include (but are not limited to):
  • Lead Clinical and Commercial analytical technology transfer for new programs and new site buildup
  • Work with analytical development teams, identify opportunities to improve assay performance and throughput, and improve overall efficiency in analytical testing
  • Provide leadership to support troubleshooting in Clinical and Commercial Quality Control during and post technology transfer
  • Direct technical 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
  • 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


Basic Qualifications:
  • Bachelor's degree in Biotechnology, Bioengineering or another relevant life-science discipline with 7+ years of industry experience in analytical development, Quality Control, technology transfers and method lifecycle management OR
  • Master's degree in Biotechnology, Bioengineering or another relevant life-science discipline with 5+ years of industry experience in analytical development, Quality Control, technology transfers and method lifecycle management


Preferred Qualifications:
  • In-depth experience with analytical method development, CMC technology transfer and cGMP requirements and testing in Clinical and Commercial Quality Control; experience with gene and cell therapies
  • 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
  • Excellent interpersonal, verbal and written communication skills
  • Ability to lead 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
  • Experience in analytical techniques such as Flow cytometry, qPCR, ddPCR, ELISA and microbiology techniques
  • Proficient in MS Word, Excel, Power Point 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
  • Self-motivated, detail-oriented, excellent interpersonal and writing skills, and willing to accept temporary responsibilities outside of initial job description


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.