Manager, Process and Product Investigations

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 09, 2020
Ref
R0015192
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 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, Manager, Process and Product Investigations will provide process and product support for process validations, comparability and GMP manufacturing for Kite's engineered autologous T cell therapy products. Additionally, you will write technical reports and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process and product quality to meet regulatory requirements.

Key responsibilities:
  • Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
  • Manage day-to-day troubleshooting activities that require in-depth understanding of cell therapy production and product history
  • Work closely with process design teams to assure process reliability and robustness in preparation for comparability and process validation.
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
  • Participate and report to a cross-functional team to advance production activities.
  • Participate in Operational Excellence activities within Tier Structure.
  • Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process and cell therapy manufacturing process validation testing)
  • Prepare and conduct initial training for process improvements and new process introduction.
  • Work flexible hours for the coverage of the production facility.
  • Other duties as assigned


Qualifications:
  • Bachelors degree in Life Sciences with at least 7+ years of biotech experience. Cell therapy experience is a must.
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for cell therapy and analytical tests
  • Technical writing and protocol/report writing is a must
  • Demonstrated knowledge of manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
  • 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.