Senior Director, Technology Development and Material Science - Process Development

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 therapy experience to lead the development of next generation of innovative T cell therapy manufacturing platform. As a Sr Director for Technology Development & Material Science in Process Development, you will provide evaluation, development and qualification of new technology/equipment and materials for cell therapy manufacturing. You will lead, facilitate and enable technology development and transfers by collaborating closely with product teams, production sites, process development and alliance management to enable approval of technology for Kite's engineered autologous and allogeneic T cell therapy products. Additionally, you will direct team in writing study design, project plans and protocols, sampling plans, production procedures, new materials qualification and sourcing. You will ensure timely completions of process development reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements. You will work with the Process Development, Business Development and Strategy, Manufacturing and Quality team to design and scale-out cell therapy processes on existing and new technology platforms through the entire CMC development and life cycle management.

Key Responsibilities include (but not limited to):

• Lead technology development and materials science group and work closely with supply chain and process engineers working on developing process equipment and automation technology with process development.
• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Work closely with process characterization teams to assure process reliability and robustness in preparation for comparability and process validation. Participate in evaluation of new technology, raw materials qualification and process automation for introduction into GMP manufacturing.
• Ensue team collaborates with internal stakeholders and external vendors and suppliers to support materials changes, secondary source qualification and define requirements and understand functional specifications
• Support investigations, identify root cause for critical deviations during process validation and determine CAPA for manufacturing
• Ensure timely completion of technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing)
• Participate and report to a cross-functional development team to advance production activities
• 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 in evaluation of new technology, materials and process automation for introduction into GMP manufacturing.

Basic Qualifications:

• BS Degree in Biochemical Engineering, Chemical Engineering or Biotechnology with 14+ years of pharmaceutical manufacturing, technology transfer & process development experience OR
• Master's degree in Biochemical Engineering, Chemical Engineering or Biotechnology with 12+ years of pharmaceutical manufacturing, technology transfer & process development experience

Preferred Qualifications:

• PhD
• Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Mastery of scientific and engineering principles
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
• 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
• Well-developed computer skills
• Pharmaceutical, Biotech products GMP manufacturing experience
• Cell culture or aseptic processing experience is a plus
• Previous experience with cell therapy products is a plus
• Equipment development and qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
• Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
• Experience in statistical analysis using JMP or Minitab
• Proven track record of leading, developing and managing direct staff and cross functional teams
• Knowledge of data management tools and statistical process controls

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.