Research Associate - Biology - I

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.

Key responsibilities:

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

Qualifications:

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

Skills:

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

Experience:

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