Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. As an Associate Director for Global MSAT, Technology Implementation you will drive tactical leadership for novel technology implementation and lifecycle management Kite’s engineered autologous T cell therapy products and viral vector programs. Operating at a global level, you will define technical requirements and lead execution of novel technology and equipment introduction into clinical and commercial manufacturing. Working cross-functionally across sites, you will generate user requirements, functional requirements, risk assessments and testing plans to ensure implementation of reliable, robust systems that perform as needed to generate product that meets patients’ needs. You will work cross-functionally with the Global MSAT, Process Design, Manufacturing and Quality teams to implement cell therapy manufacturing technology to multiple sites, establish novel technology and equipment qualification strategies and oversee process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.
Evaluate and Design
- Work cross-functionally and participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
- Work with vendors and suppliers to define requirements and review and functional specifications.
- Lead Design Reviews and Design Qualifications (DR/DQ).
- Provide technical input for qualification requirements including technical support for equipment qualification standards, framework for harmonized risk-based qualification strategies for similar equipment and unit operations across plants and alignment of PQ activity with process and operational requirements.
- Write, Review/Approve technical documentation such as URS, FRS, equipment functional risk assessments, documentation for FATs, SATs, IQ/OQ/PQ testing.
- Interface internally with process design, analytical development, technical development, Global/Site MSAT and process technical leads and cross-functionally with Quality, Manufacturing and Engineering to implement new processes and technology as part of technology transfers.
- Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues Other technical duties as assigned.
- Provide technical support for investigations, identify root cause for critical deviations
- Be capable of developing, growing and leading technical talent in cell therapy equipment lifecycle management. · As part of product and process lifecycle requirements, define and establish sound scientific approaches for risk evaluation of global process change impact on process validation and comparability.
- Degree in Engineering, Science, Biotechnology or related discipline. BS with 10+ years of pharmaceutical manufacturing equipment, technology transfer, design or process development experience required or 8+ years of relevant experience and a MS/MBA
- Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Mastery of scientific and engineering principles
- Demonstrated knowledge of sterile manufacturing of cell therapy, biopharmaceutical or pharmaceutical
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Ability to seek cross-functional alignment and prioritize options based on Kite goals and strategies
- 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
- Well-developed computer skills
- Must have 8+ years of equipment and process validation, technology transfer or pharmaceutical manufacturing experience
- Pharmaceutical products GMP manufacturing experience is a must
- Understands and employs principles and concepts of ISA 88 standard for batch anufacturing to improve capability and flexibility of automated equipment
- Cell culture or aseptic processing experience is a plus
- Previous experience with cell therapy products is a plus · Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred utilizing risk based tools based on E2500; process development or process validation experience is a plus
- Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
- Proven track record of leading and managing cross functional teams
- Knowledge of data management tools and statistical process controls