Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of Client cancer immunotherapy products designed to harness the power of a patients own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.
Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment at a new research and clinical production facility located in Gaithersburg, Maryland. This facility will focus on the new challenging field of fully personalized T cell neoantigen reactive therapy for solid tumors using individual patient neoantigen TCRs. As a Research Associate / Associate Engineer in Process Development, you will provide process development support for New INDs, technology transfers, process validations and GMP manufacturing for Kites neoantigen TCR therapy product. Additionally, you will draft and review protocols, production procedures, and process development reports. You will work with the Viral Vector Process Development team to design and scale-out cell therapy processes, manage equipment qualification and support process validation, as well as draft documentation for regulatory filings to advance Kites product portfolio.
Hands on execute and collaborate on process design laboratory studies to support process development, optimization and characterization and essential viral vector process improvements.
Perform hands on work in a cell culture lab and process training for GMP clinical production.
Participate and influence a cross-functional development team to advance CMC activities
Perform process analysis and trend process performance
Develop manufacturing processes for cell therapy products
Design and execute process development studies to develop a thorough understanding of operating and performance parameters
Perform statistical analysis including design of experiments (DOEs) as appropriate
Write and review technical documentation from writing technical SOPs, draft manufacturing batch records, technical reports and summary reports.
Other duties as assigned
Degree in Biology, biochemistry or biotechnology degree or related discipline with 1-2 years of pharmaceutical manufacturing, technology transfer & process development experience required
Demonstrated cell culture and aseptic processing experience is required including basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, and managing reagents.
Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with bioreactors is desired.
Mastery of scientific and engineering principles
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
Ability to think critically, and demonstrated troubleshooting and problem solving skills
Excellent interpersonal, verbal and written communication skills are required.
Ability to function efficiently and independently in a changing environment
Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description
Well-developed computer skills
High energy level and a positive outlook coupled with the requisite can do attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace, dynamic team setting
Must have 1-2 years of pharmaceutical process development experience
Pharmaceutical products GMP manufacturing experience is desired
Cell culture or aseptic processing experience is a plus
Previous experience with cell therapy products is a plus
Understands and employs principles and concepts of Lean Six Sigma or design of experiments to improve process capability is a plus
Experience in statistical analysis using JMP or Minitab
Proven track record of working within cross functional teams
Knowledge of data management tools and statistical process controls