Associate Director, Process Engineering

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Nov 08, 2020
Ref
R0016064
Required Education
Doctorate/PHD/MD
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 individual with cell culture experience to work on innovative T cell therapy for cancer treatment. Reporting to the Head of Site Manufacturing Sciences and Technology, Associate Director, Process Engineering is a key leadership role within Kite Pharma's Process Development and Technical Operations. As an Associate Director you will provide technical and organizational leadership support to the commercial manufacturing for cell therapy. As a member of Site MSAT Leadership Team you are expected to oversee MSAT team's responsibilities for product/process response and investigations, project management, and process improvements. The ideal candidate must have experience in cell therapy and/or biologics, GMP manufacturing and excellent understanding of regulations.

Key responsibilities:
  • Lead continuous improvement projects supporting commercial manufacturing site
  • Lead or support technology transfers of launch and commercial cell therapy products
  • Provide leadership to execution of process validation and comparability campaigns
  • Review and provide technical expertise to regulatory filings and health authority questions
  • Effectively & efficiently communicate manufacturing process performance internally and externally.
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Support the implementation of technology, automation and IT infrastructure projects
  • Develop and lead all aspects of the MSAT team's contribution towards investigations, impact assessment, new process training
  • Design and execute scientific laboratory studies to support process/product understanding and continuous improvement projects
  • Review and approve technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation)
  • Lead/participate in Operational Excellence activities
  • Participate and report to a cross-functional development team to advance production activities
  • Other duties as assigned


Basic Qualifications:
  • PhD in Biochemical Engineering, Biotechnology or Life Sciences with 2+ years of biotech experience.
  • Masters Degree in Biochemical Engineering, Biotechnology or Life Sciences with 8+ years of biotech experience.
  • Bachelors Degree in Biochemical Engineering, Biotechnology or Life Sciences with 10+ years of biotech experience.


Preferred Qualifications:
  • Cell therapy experience
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • In-depth understanding of scientific and engineering principles
  • Strong written and verbal communication skills
  • Proven track record of leading and managing cross functional teams
  • Previous experience with people leadership
  • Experience in statistical analysis using JMP or Minitab
  • Knowledge of data management tools and statistical process controls
  • Process validation experience
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability
  • Understand manufacturing needs and adapt to the changing needs of the manufacturing environment
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description


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.