Process Engineer III, Vector Process Development Fill Finish

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 10, 2020
Ref
R0015164
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 Process Engineer with drug product experience to join the Viral Vector Process Development team. The candidate will be passionate about fill/finish activities, including process design, process characterization, engineering, and continuous process improvement support for sterile filtration, formulation, fill, freeze and thaw unit operations. The primary responsibility will be to establish robust fill/finish processes by leading and executing lab studies to define scale-down/-up models, and to define drug product process parameters that maintain Critical Quality Attributes of the viral vector. Additionally, the candidate will provide technical support for engineering and process changes in cross-functional project teams that help drive the Kite pipeline.

Responsibilities include, but are not limited to:
  • Lead and execute screening studies to identify target process parameters in early stage development of sterile filtration, mixing, filling, freezing and thawing unit operations utilizing designs of experiments (DoEs)
  • Conduct and facilitate risk assessments to identify critical process parameters (CPPs) and guide late stage characterization studies with the intent of establishing proven acceptable ranges (PARs) through scale-down models of fill/finish unit operations
  • Optimize final formulations in collaboration with the downstream process development team to ensure formulations meet criteria for both downstream and final/fill processes
  • Design and execute stability studies that characterize the degradation/inactivation of viral vector product under accelerated and long-term storage conditions
  • Conduct compatibility studies and closure integrity studies of primary drug container systems, such as vials, stoppers, and bags in collaboration with packaging engineering and validation teams
  • Assist in technology transfer to GMP manufacturing by generating development reports, participating in cross-functional teams, offering technical solutions for site-specific limitations, providing on-site technical support and training, and conducting gap assessment or process improvement studies identified during tech transfer
  • Be an effective communicator of ideas, project goals and results to cross-functional departments/meetings in both written and presentation format. The candidate should be able to make key insights to data and develop solutions in a collaborative multidisciplinary environment.
  • This is a hands-on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.
  • Other duties as assigned


Requirements:

Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology or a related discipline with 4+ years of relevant industry experience that demonstrates expertise in drug product process development as well as sustained excellence in performance and accomplishments that align to company goals.

Previous experience with cell therapy products, a cGMP environment, process automation, design and troubleshooting for new machines and devices is desirable

Mastery of scientific and engineering principles with strong scientific writing and presentation skills to clearly communicate to cross-functional teams

Previous experience with definition and characterization of a late-stage process control strategy, process validation and commercial technology transfer is preferred

Experience in statistical analysis using JMP or Minitab

Document work accurately and timely using good documentation practices

Ability to think critically, and demonstrated troubleshooting and problem-solving skills

Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Self-motivated and willing to accept temporary responsibilities outside of initial job description

The primary location of the position is Santa Monica, but may be required to travel, based on business priorities

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.