Senior Manager, Process Design

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 13, 2020
Ref
R0016116
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

Kite is seeking a highly motivated leader with process development experience to work on innovative T cell therapy for cancer treatment.The individual will be a member of autologous process design (autologous PD) leadership as a second pipeline group leader and represent autologous PD team in cross-functional meetings under the guidance of the lead of autologous PD team and the head of process design. The individual will be accountable for delivering functional milestones to support CMC activities at various stages (pre-IND, post-IND, and pre-BLA) for autologous products at Kite by providing technical expertise in technology transfer, GMP manufacturing support and also by providing approval for documentation pertaining to feasibility, process development and tech transfer to manufacture to meet regulatory requirements.The individual will work with other autologous PD group leaders (both early and late stage programs) to facilitate technology transfer to LCM group and also influence early programs at Kite by providing important lesson and learnt. The individual will manage a small group within the autologous PD and oversee activities of pipeline programs at Kite such as risk assessment, IND planning and execution, and tech transfer documentation.

Responsibilities include, but are not limited to:
  • Manage a small autologous PD pipeline group to deliver functional milestones to support CMC activities
  • Work with autologous PD lead to provide technical guidance to her/his group for high quality data analysis and interpretation using advanced analytical tools (JMP, DX) for process characterization
  • Participate tech transfer meetings and other cross-functional discussion as process SME to advance product activities
  • Work with autologous PD lead to oversee and provide expertise on regulatory commitment
  • Provide guidance to ensure successful clinical manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues


Skill sets:
  • 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
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skill
  • Demonstrates excellent verbal communication skills and interpersonal skills
  • 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


Requirements:
  • Must have 3+ years of pharmaceutical process development experience
  • Pharmaceutical products GMP manufacturing experience
  • Cell culture or aseptic processing experience
  • Previous experience with cell therapy products
  • Understands and employs principles and concepts of Lean Six Sigma or design of experiments to improve process capability
  • 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


Basic Qualifications:
  • Bachelors Degree in Biology, biochemistry, chemical engineer, biomedical engineering or biotechnology degree or related discipline with 8+ years of pharmaceutical manufacturing, technology transfer & process development experience
  • Masters Degree in Biology, biochemistry, chemical engineer, biomedical engineering or biotechnology degree or related discipline with 6+ years of pharmaceutical manufacturing, technology transfer & process development experience


Preferred Qualifications:
  • 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.
  • Experience with bioreactors
  • Mastery of scientific and engineering principles
  • Well-developed computer skills


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.