Executive Director, Analytical Development - Cell Therapy

职位描述

Kite is seeking a highly motivated Executive Director, Analytical Operations with method development and analytical life cycle management and tech transfer experience to work on innovative T cell therapy for cancer treatment. The Executive Director will work with Process Development, Research, Translational Medicine, and Quality organizations to provide process and analytical development and CMC leadership to a team responsible for analytical characterization of cell therapy products, maturation of research analytical methodology into development and GMP, and analytical method transfer from/ to Kite contract vendors. They will have excellent people leadership abilities and be responsible for overseeing laboratory studies, analyzing experimental data, and assuring careful documentation of resultant information.

Responsibilities include (but are not limited to):

• Lead Analytical activities in support of viral vectors and engineered T cell products, including establishment of analytical control system strategy and identification of CQAs
• Design, develop, implement, and document analytical method development and qualification in support of process development, product release and stability, and product characterization of viral vector and T cell therapies in Process Development
• Identify, develop, and implement phase-appropriate analytical technologies and methods to study and characterize processes for production of viral vector and T cell therapies, including process improvements and efficiencies
• Lead and implement quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines
• Lead analytical laboratory staff in the selection, design and implementation of novel methods reflective of mechanism of action, including FACS/flow cytometry, with emphasis on automation and high throughput technologies to enable commercial readiness
• Manage method and analytical technology transfers to/ from contract testing labs and Kite facilities as appropriate
• Lead the analytical arm of OOS investigations, deviations and CAPAs
• Ensure standard operating procedures, test methods, sampling plans, batch records, and monitoring, trending and improvement process for all Kite analytical methods meet the highest industry standard
• Lead data digitization and automation in support of viral vector and engineer T cell products including implementation of ELN systems, back-end infrastructure, and front-end user tools
• Draft and review of CMC sections and supporting documents for Regulatory filings. Participate in PAI, defend regulatory audits and draft responses
• Responsible for personnel recruitment, development, and retention
• Responsible for budget forecasting including resource modeling and CAPEX
• Ensure a collaborative work environment with key client groups in Research, Quality, Manufacturing and Process Development to support analytical method and process development as well as the characterization of Kite’s T cell products, e.g., lead maturation of research analytical methodology into Development and GMP, and method technology transfer to and from Kite partners

Basic Qualifications:

• Ph.D. in Chemistry, Biochemistry, Biology, or related discipline with 14+ years of leadership experience in the biotech and/or pharmaceutical industry OR
• MS Degree. in Chemistry, Biochemistry, Biology, or related discipline with 14+ years of leadership experience in the biotech and/or pharmaceutical industry OR
• BS Degree. in Chemistry, Biochemistry, Biology, or related discipline with 16+ years of leadership experience in the biotech and/or pharmaceutical

Preferred Qualifications

• Demonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, analytical method development, technology transfer, and method qualification/validation and process development
• Advanced degree strongly preferred
• Demonstrated ability to work with both reporting organization and senior leadership teams
• Excellent interpersonal - verbal and written communication skills
• Ability to lead a diverse, savvy technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others
• Expertise with analytical method development and qualification and analysis of cell therapy products
• Well versed in various analytical techniques such as flow cytometry, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.
• Excellent understating of cellular processes and metabolism and experience working with human primary cells, including T cells, and viral vectors
• Knowledge of QbD approaches to analytical method development including DOE, risk assessment and statistical analysis
• Deep knowledge of technical writing for Post-Approval Changes, BLA, IND
• Proficient in MS Word, Excel, PowerPoint, and other applications
• Comfortable in a dynamic, growing company
• Agile mindset and ability to adjust workload based upon changing priorities
• Creative and thoughtful problem-solving skills
• Able to take a proactive, solution-oriented approach
• Excellent interpersonal communication skills, including the ability to listen well and appropriately inform and guide stakeholders
• Ability to work in, lead and foster cross-functional, collaborative teams
• Ability to effectively present results and proposals to audiences of all levels
• Experience supporting, developing, and mentoring staff and creating inclusive, high-performing teams
• Ability to foster an organization that demonstrates integrity, accountability, teamwork, and excellence
• Someone who leads by example