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Director Allogeneic Process Development

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description

Director Allogeneic Job Description

Kite is seeking a highly motivated leader with cell therapy experience to work on innovative T cell therapy for cancer treatment. The Director, Allogeneic Process Design will provide leadership for process development, technology transfer and support of GMP manufacturing of Kite’s engineered allogeneic T cell therapy products. As a Director of Allogeneic Process Design, you will perform gap assessment, recommend improved process design and scale-up cell manufacturing processes. Your responsibilities will include management of all process changes and provide technical assessment and approval for engineering and process changes, as well as management of documentation pertaining to process development, qualification, and validation to support regulatory filings to advance Kite’s product portfolio. In addition, you will interact cross-functionally to support product and process characterization for Kite’s allogeneic T cell products, as well as to lead technical investigations.

 Responsibilities:

• Lead allogeneic process transfer and implementation into clinical manufacturing

• Support process transfer documentation including BOM, SOPs, batch records and FMEA to enable Engineering runs

•Ensure successful clinical manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues

•Design manufacturing processes for cell therapy products and develop process improvements and efficiencies including incorporation of new technology and process automation

•Lead allogeneic process development and process characterization studies, analyze data, review and approve technical documentation

•Design and execute process characterization studies to develop a thorough understanding of operating and performance parameters

•Manage process development reports and documentation to support regulatory filings

Basic Qualifications:

• PhD in Biochemical Engineering, Chemical Engineering or Electrical / Computer Engineering with 8+ years of experience in pharmaceutical manufacturing, technology/software development

OR

• MS in Biochemical Engineering, Chemical Engineering or Electrical / Computer Engineering with 10+ years’ of experience in pharmaceutical manufacturing, technology/software development

OR

• BS in Biochemical Engineering, Chemical Engineering or Electrical / Computer Engineering with 12+ years’ of experience in pharmaceutical manufacturing, technology/software development

OR

High School Degree and 16+ years’ of experience in pharmaceutical manufacturing, technology/software development

Preferred Qualifications:

• Experience in development of Cell Therapy processes and/or cellular immunology

• Previous experience with adult and pluripotent stem cells processes is a plus

• Cell therapy equipment development and qualification experience in a cGMP environment (IQ, OQ, PQ) is a plus

• Knowledge of data management tools and statistical process controls is a plus

• Mastery of scientific and engineering principles

• 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