Senior Research Associate, Downstream Process Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 25, 2020
Ref
R0016222
Required Education
Bachelors Degree
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

This individual will be an integral member of the downstream process development of the viral vector programs at Kite, contributing to the development, scale up and technology transfer of the viral vector production process. These activities can include ultrafiltration, microfiltration, chromatography, depth filtration, impurity characterization, scale-down model development and qualification, process optimization, robustness studies, and process characterization.

In addition this individual in collaboration with our technical operations group will support process technology transfer activities, due diligence and facility fit assessment for internal and external manufacturing facilities. The candidate will also support development of downstream technology platforms to improve vector recovery, purity and stability.

Key Responsibilities

  • Design and execute process development studies to develop a thorough understanding of operating and performance parametersand identify process efficiencies to be made
  • Perform normal flow and tangential flow filtration operations, chromatographic separations, in-process analytical testing (UV spectroscopy, HPLC, gel electrophoresis, ELISA, turbidity) as required
  • Develop manufacturing processes for viral vector products and support process scale up and implementation into GMP clinical production suites
  • Perform process analysis and trend process performance
  • Write and review technical documentation
  • Selects appropriate methods and techniques in performing research and process.
  • Collaborates with colleagues to develop methods.
  • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
  • Acts as a resource for other employees within the department.
  • Maintains familiarity with scientific literature and applies appropriately to research projects.
  • Demonstrates strong verbal communication skills and interpersonal skills.
  • Works with collaborative communication and problem solving spirit.


Required Skills:

  • Knowledge of chromatography (i.e. modes of operation, column packing/qualification), ultrafiltration, scale-up and engineering principles (e.g. residence time, critical flux, proper dimensions for scaling-up)
  • Hands on expertise with laboratory-scale FPLC instruments (i.e. AKTA/Unicorn) and TFF/NFF systems (i.e. PendoTech).
  • Previous experience running molecular biology assays (ELISAs, gel electrophoresis, flow cytometery) is desired.
  • Demonstrated excellence in viral vector or biologics downstream process development, process technology transfer, scale translation, and statistical DOE (design of experiments)
  • Excellent communication and presentation skills and aptitude for problem solving
  • Experience with the preparation of regulatory filings for US and external markets is desired
  • Candidate should be self-motivated, ambitious, organized, and collaborative
  • Act as an effective and committed team player


Basic Qualifications:
  • 2+ years of experience with BS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
  • 0+ years of experience with MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
  • High school diploma with 5+ years of experience


Preferred Qualifications:
  • Previous experience with TFF ultrafiltration for biologics or viral vectors is required. Experience with the development of viral vector purification process trains.
  • Previous experience with molecular biology and biophysical techniques (ELISA, HPLC, gel electrophoresis, PCR, particle size determination).
  • Experience with statistical experimental design (i.e. DOE studies) and automation technologies.
  • Practical experience of cGMP manufacturing operations and fluency of regulatory regulations.
  • Ability to think critically, and demonstrate troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skillsare essential.
  • Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description
  • 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 and dynamic team setting.
  • 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.


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

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.